Volume
4 • Issue 4 • 1000137
J
Develop Drugs
ISSN:
2329-6631 JDD an open access journal
Case
Report
Open
Access
Journal of
Developing Drugs
s
ISSN:
2329-6631
Arumugham,
J
Develop Drugs
2015,
4:4
http://dx.doi.org/10.4172/2329-6631.1000137
Keywords:
Vaccines;
Food allergy; Adjuvant; Anaphylaxis;
Precautionary
principle; Prudent avoidance
Abbreviations:
VAERS:
Vaccine Adverse Event Reporting System;
DTaP:
acellular pertussis vaccine combined with diphtheria and tetanus
toxoids;
IgE: Immunoglobulin E; MMR: Measles, Mumps and Rubella
vaccine;
FDA: Food and Drug Administration; USP: United States
Pharmacopeia;
NIH: National Institutes of Health; NIAID: National
Institute
of Allergy and Infectious Diseases; IOM: Institute of Medicine
Background
More than
15 million Americans are estimated to suffer life-threatening
food
allergies. Many studies looking into the cause of food allergies do not
seem to
consider vaccines or injections as a cause [1,2,3].
Evidence
Brief
history of allergens in vaccines and injections inducing
allergy in
healthy individuals
Nobel
Laureate Charles Richet demonstrated over a hundred years
ago that
injecting proteins into humans or animals causes immune
system
sensitization to that protein. Subsequent exposure to the
same protein
can result in anaphylaxis. Let’s call it the Richet allergy
model.
Wells [4] demonstrated in 1908 that injecting as little as 50 ng
of
ovalbumin into guinea pigs resulted in sensitization. Subsequent
injections
of ovalbumin resulted in an allergic reaction.
In 1940,
Cooke et al. [5] describe induction of allergy by a tetanus
vaccine. In
1952, Ratner et al. [6] were concerned about the possibility of
sensitization
to egg following the administration of influenza vaccines
that are
manufactured using chicken eggs. They studied a group of
319
subjects and found that 5 of them developed dermal sensitivity to
egg
following vaccination with vaccines containing egg proteins. All
the
subjects in the study were undergoing treatment for tuberculosis.
The authors
probably did not know that tuberculosis infection may
offer
protection against allergy [7]. They therefore found sensitization
in 1.6% of
vaccine recipients, even in a population that was protected
from
allergy, by tuberculosis infection. Yamane et al. [8] demonstrated
a
significant increase in anti-ovalbumin IgE in 36 out of 100 subjects
following
influenza vaccination.
In 1999,
Nakayama et al. [9] found evidence of a causal relationship
between
administration of acellular pertussis vaccine combined with
diphtheria
and tetanus toxoids (DTaP) and the development of gelatin
allergy.
Following this study, in 2003, Kuno-Sakai et al. [10] used gelatin-
free DTaP
vaccine to demonstrate that the development of gelatin allergy
Abstract
Nobel
Laureate Charles Richet demonstrated over a hundred years ago that injecting a
protein into animals or
humans
causes immune system sensitization to that protein. Subsequent exposure to the
protein can result in allergic
reactions
or anaphylaxis. This fact has since been demonstrated over and over again in
humans and animal models.
The
Institute of Medicine (IOM) confirmed that food proteins in vaccines cause food
allergy, in its 2011 report on vaccine
adverse
events. The IOM’s confirmation is the latest and most authoritative since Dr.
Richet’s discovery. Many vaccines
and
injections contain food proteins. Many studies since 1940 have demonstrated
that food proteins in vaccines cause
sensitization
in humans. Allergens in vaccines are not fully disclosed. No safe dosage level
for injected allergens has
been
established. As a result, allergen quantities in vaccines and injections are
not regulated. Allergen quantities in
vaccine
excipients are also not regulated. It has been demonstrated that a smaller quantity
of allergen is needed to
cause
sensitization than elicitation. It is well recognized that many currently
approved vaccines have enough allergen to
cause
anaphylaxis. Therefore, they contain more than enough allergen to cause
sensitization. Children today have fewer
childhood
infectious diseases. They have less exposure to helminths. C-section birth
rates have increased in the last
few
decades by 50%. C-section births are known to result in sub-optimal gut
microbiome in the newborn. All the above
result
in an immune imbalance biased towards atopy. Vaccine schedules today include
30-40 shots. Up to five shots
may be
simultaneously administered in one sitting. Vaccines contain adjuvants such as
pertussis toxins and aluminum
compounds
that also bias towards allergy. Adjuvants also increase the immunogenicity of
injected food proteins. This
combination
of atopic children and food protein injection along with adjuvants, contributes
to millions developing life-
threatening
food allergies. Given the scale and severity of the food allergy epidemic,
urgent action is needed to change
vaccine
policy concerning vaccine specifications, manufacture, vaccine package insert
documentation requirements,
the
Vaccine Adverse Event Reporting System (VAERS) and the National Vaccine Injury
Compensation program.
Many
researchers have called for the removal of food proteins from vaccines and
re-evaluation of adjuvants such as
aluminum
compounds. In the interim, food allergy warnings can be included in vaccine
package inserts. Simultaneous
administration
of multiple vaccines can be stopped to avoid the combined negative effects of
multiple food proteins and
adjuvants.
*Corresponding
author:
Vinu
Arumugham, San Jose, CA, USA, E-mail:
vinucube@yahoo.com
Received
October
01
, 2015
;
Accepted
October
05
, 2015
;
Published
October
10
,
2015
Citation:
Arumugham
V
(2015)
Evidence
that Food Proteins in Vaccines Cause the
Development
of Food Allergies and Its Implications for Vaccine Policy.
J
Develop Drugs
4: 137.
doi:
10.4172/2329-6631.1000137
Copyright:
© 2015
Arumugham
V
. This
is an open-access article distributed under
the
terms of the Creative Commons Attribution License, which permits unrestricted
use,
distribution, and reproduction in any medium, provided the original author and
source
are credited.
Evidence
that Food Proteins in Vaccines Cause the Development of Food
Allergies
and Its Implications for Vaccine Policy
Vinu
Arumugham*
San Jose, CA, USA
Citation:
Arumugham
V
(2015)
Evidence
that Food Proteins in Vaccines Cause the Development of Food Allergies and Its
Implications for Vaccine
Policy.
J
Develop Drugs
4: 137.
doi:
10.4172/2329-6631.1000137
Page 2
of 3
Volume
4 • Issue 4 • 1000135
J
Develop Drugs
ISSN:
2329-6631 JDD an open access journal
was indeed
caused by gelatin present in the DTaP vaccines. In 2009, the
US Dept. of
Health and Human Services (HHS) charged the Institute of
Medicine
(IOM) with providing a thorough review of the current medical
and
scientific evidence on vaccines and vaccine adverse events.
The IOM has
concluded in its 2011 report that
“Adverse
events on our list thought to be due to IgE-mediated
hypersensitivity
reactions Antigens in the vaccines that the committee
is charged
with reviewing do not typically elicit an immediate
hypersensitivity
reaction (e.g., hepatitis B surface antigen, toxoids,
gelatin,
ovalbumin, casamino acids). However, as will be discussed in
subsequent
chapters, the above-mentioned antigens do occasionally
induce
IgE-mediated sensitization in some individuals and subsequent
hypersensitivity
reactions, including anaphylaxis” [11]. Ovalbumin
would of
course result in sensitization to egg. Casamino acid is derived
from milk
proteins and results in allergy to dairy.
Allergens
contained in vaccines
Vaccines
and injections contain food proteins such as chicken egg,
casein,
gelatin, soy, agar etc. [12]. They also contain ingredients such
as
Polysorbate 80 and sorbitol which are manufactured using food
sources.
Checking with a few suppliers, Polysorbate 80 is sourced from
various
food items such as coconut, palm, sunflower, tapioca, wheat,
corn etc.
Other vendors could be using other vegetable oils, legume
oils and
nut oils as the source for oleic acid used in the manufacture of
Polysorbate
80. It is impossible to guarantee that these products do not
contain
residual allergen proteins from these food sources.
No
specification to limit allergen content in vaccines
I was able
to confirm with the Food and Drug Administration
(FDA), the
United States Pharmacopeia (USP) and vaccine maker
Sanofi
Pasteur that there are no specifications limiting allergen content
in vaccines
approved for use in the United States. In other words, no
safe level
has been established or enforced for allergens contained
in
vaccines. Vaccine excipient makers such as sorbitol, Polysorbate
80
manufacturers also have no limits on residual allergens in their
injectable
grade products. Since there are no limits, suppliers do not
test for
allergens in production. Further, residual allergens that may
be present
in the excipients are not even listed in the vaccine package
inserts.
O’Brien et al. [13] measured 7.4 mcg/ml of ovalbumin in
influenza
vaccines in 1967. Goldis et al. [14] measured as much
as 38.3
mcg/ml in influenza vaccines as recently as 2008. The above
observations
are an obvious consequence of the lack of specifications
or
regulation of allergen content in vaccines.
Effect of
adjuvants and multiple simultaneous vaccinations
Pertussis
toxin and aluminum compounds act as adjuvants. These
adjuvants
are known to bias for IgE synthesis [15]. Injecting food
proteins
along with these adjuvants increases the immunogenicity of
the food
proteins that are present in the vaccines. With up to five shots
administered
simultaneously, numerous food proteins and adjuvants
get
injected at one time. This increases the probability of sensitization.
Atsuko et
al. [15] not only accepted that vaccine antigens and
vaccine
components induced allergies, they also acknowledge the role
of aluminum
in IgE synthesis. Hence they worked on an alternative to
aluminum
based adjuvants.
Sensitization
needs less injected allergen than elicitation
As
demonstrated by Wells [4], the sensitization dose can be as
little as
50 ng of ovalbumin. The elicitation dose was 25 mg. Likewise,
Nakayama et
al. [9] found that gelatin content in DTaP (48-200 mcg)
was
sufficient to cause sensitization but not enough to cause elicitation.
MMR
contained enough gelatin (0.2%) to result in elicitation [16].
DTaP
followed by DTaP:
Result:
Sensitization but no elicitation.
DTaP
followed by MMR:
Result:
Sensitization followed by
elicitation.
Therefore,
it is clear that any vaccine or injection that contains
enough
allergen to cause anaphylaxis has more than enough allergen
to cause
sensitization. Most vaccines have been known to cause
anaphylaxis.
So most vaccines contain more than enough allergen to
cause
sensitization.
Animal
models and other similar allergy inducing mechanisms
The Richet
allergy model is often used in the laboratory to induce
food
allergy in mice. Food proteins are commonly injected into mice
along with
alum as an adjuvant [17]. This is no different from vaccines
containing
food proteins along with adjuvants such as alum being
injected
into people.
There is
also evidence of this allergy mechanism at work with tick
bites. Tick
bites have been shown to inject alpha-galactose into the
body of the
victim. The victim develops sensitivity to alpha-galactose.
Since red
meat contains alpha-galactose, the victims develop red meat
allergy
[18]. We have therefore seen multiple, varied and independent
confirmations
of Charles Richet’s discovery in both humans and
animal
models.
Summary
Numerous
studies have demonstrated that food proteins contained
in
vaccines/injections induce food allergy. The IOM’s authoritative
report has
concluded the same. Allergen quantities in vaccines are
unregulated.
Today kids are more atopic. C-section births bias the
newborn’s
immune system towards IgE synthesis due to sub-optimal
gut
microbiome [19]. C-section birth rates have gone up 50% in the last
few
decades. The vaccine schedule has increased the number of vaccine
shots to
30-40 and up to five vaccines are simultaneously administered
to
children. Vaccines also contain adjuvants such as aluminum
compounds
and pertussis toxin that bias towards IgE synthesis. Given
these
conditions, the predictable and observed outcome is a food
allergy
epidemic.
Action
Obviously,
as Kuno-Sakai et al. [10] have concluded, phasing out
food
proteins from vaccines and injections as soon as possible would
be the real
solution for food allergies caused by vaccines and injections.
Goldis et
al. [13] have suggested alternative vaccine manufacturing
methods to
avoid contamination of vaccines with egg proteins.
Kattan et
al. [20] have suggested eliminating casein from vaccines.
Mark et al.
[21] have suggested re-evaluation of aluminum compounds
in vaccines
due to its undesirable bias towards IgE synthesis.
Meanwhile,
urgent action is needed to limit the problem. Unlike
anaphylaxis,
food allergies caused by vaccines may only be diagnosed
weeks or
months after vaccination.
If doctors
are not informed of a possible link between vaccines and
food
allergies, either by vaccine package inserts or by peer reviewed
published
papers, [1,2,3] how are they going to make the connection
and report
the event to the Vaccine Adverse Event Reporting System
(VAERS)?
This makes VAERS ineffective to study this problem. The
Citation:
Arumugham
V
(2015)
Evidence
that Food Proteins in Vaccines Cause the Development of Food Allergies and Its
Implications for Vaccine
Policy.
J
Develop Drugs
4: 137.
doi:
10.4172/2329-6631.1000137
Page 3
of 3
Volume
4 • Issue 4 • 1000135
J
Develop Drugs
ISSN:
2329-6631 JDD an open access journal
Precautionary
principle [22] states that lack of scientific consensus is
not a
reason for inaction when public safety is at risk. This principle
is used by
policy makers worldwide. Prudent avoidance [23] is a
precautionary
principle in risk management, stating that reasonable
efforts to
minimize potential risks should be taken when the actual
magnitude
of the risks is unknown. Applying prudent avoidance means
we should
immediately stop multiple vaccines being administered
simultaneously.
It is likely to reduce the probability of developing
food
allergies by reducing the amount, number of food proteins and
adjuvants
that are injected at one time. Perhaps no more than a vaccine
a month
should be allowed.
Using the
precautionary principle, we should add a warning in
vaccine
package inserts about food allergy being a possible side effect.
This will
improve reporting and make VAERS useful in studying the
problem
further. The National Vaccine Injury Compensation Program
requires
victims to prove that the vaccine caused the injury. According
to the
precautionary principle, the burden of proof of product safety
should fall
on those producing, approving and prescribing the vaccine
and not on
the victims.
Acknowledgments
I would
like to acknowledge informative discussions with Dr. Polly Matzinger
(NIH/NIAID)
and Dr. Calman Prussin (NIH/NIAID).
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Citation:
Arumugham
V
(2015)
Evidence
that Food Proteins in Vaccines Cause
the
Development of Food Allergies and Its Implications for Vaccine Policy.
J
Develop
Drugs
4: 137.
doi:
10.4172/2329-6631.1000137
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