The purpose of vaccine adjuvants is to optimize
the body’s immune response to vaccine antigens but these substances are not
without risks and side effects. Aluminum is a naturally occurring metal, a
known human toxin and the most commonly used vaccine adjuvant. Aluminum compounds, specifically
aluminum salts are the main adjuvants approved for use in human vaccines.1 2 3
According to MedScape,
“Aluminum is absorbed…parenterally4 [this means administered by injection] via immunizations [vaccines]...If a significant aluminum load
exceeds the body's excretory capacity, the excess is deposited in various
tissues, including bone, brain, liver, heart, spleen, and muscle. This
accumulation causes morbidity and mortality through various mechanisms.”5
[emphasis mine]
Calcium
Inhibition
Aluminum is known to disrupt the
body’s absorption of calcium, an essential mineral for bone and brain cell
development.6
So important is the role of calcium to brain development that calcium
deficiency during early life stages is associated with central nervous system
diseases like autism and mental retardation.7
By disrupting calcium absorption, aluminum not only interferes with proper
brain development, it is also associated with various bone diseases and is
particularly hazardous to individuals of compromised physiological function.8 According to the Handbook for Toxicology of Metals, “Reduced renal [kidney] function markedly increases the risk of aluminum
accumulation.”9 [emphasis mine]
In 2001, the FDA corroborated this fact by amending its regulation of
aluminum content in large and small volume parenteral
drug products (intravenous drugs and nutrition). In doing so, the FDA cited several studies10 demonstrating a
positive relationship between aluminum accumulation and various central nervous
system (CNS) and bone diseases. The FDA document
states,
“Generally, when medication and nutrition are administered orally, the
gastrointestinal [GI] tract acts as an efficient barrier to the absorption of
aluminum, and relatively little ingested aluminum actually reaches body
tissues. However, parenterally administered drug products containing aluminum bypass the protective
mechanism of the gastrointestinal tract and aluminum circulates and is
deposited in human tissues...Research indicates that neonates [infants] and patient
populations with impaired kidney function may be at high risk of exposure to unsafe
amounts of aluminum…patients with impaired kidney
function, including premature neonates, who receive parenteral levels of aluminum
at greater than 4 to 5 microg/kg/day accumulate
aluminum at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration.”11 [emphasis mine]
While this document’s purpose is to amend aluminum regulations for
intravenous drugs and nutrition products, the FDA’s statements regarding
aluminum accumulation from parenterals make it clear
that parenterally administered aluminum exceeding 4-5mcg/kg/day
is associated with CNS and bone diseases. Perhaps this is because when
aluminum is injected into the body (bypassing the
protective barrier of the GI tract) 100
percent of the aluminum circulates in the body making it more readily absorbed
by human tissues, including but not limited to the bones and brain.3
As a 2013 study published by Kahn et al in BioMed Central Journal finds,
“Intramuscular injection of alum-containing vaccine was associated with the
appearance of aluminum deposits in distant organs, such as spleen and brain
where they were still detected one year after injection.”12 [emphasis mine]
Kahn et al conclude,
“Alum has high neurotoxic potential, and planning
administration of continuously escalating doses of this poorly biodegradable adjuvant in the population should be carefully
evaluated by regulatory agencies since the compound may be insidiously unsafe.
It is likely that good tolerance to alum
may be challenged by a variety of factors including overimmunization, BBB
[blood-brain barrier] immaturity, individual susceptibility factors, and
aging…”12
[emphasis mine]
Infant Renal
Function
Clearly aluminum compounds can be hazardous to the human system,
particularly when administered by means of injection and especially if the
individual has reduced or impaired kidney function. Upon further research on
the role the kidneys play in excretion of aluminum from the body, what I
discovered about the renal status of infants implies dismal outcomes for
infants receiving injections of aluminum.
Glomerular
filtration rate (GFR) is a measure used to assess proper kidney function. When
reported GFR is below 90ml/min/1.73 m, the individual is said to have
"reduced or impaired kidney function.” According to a text book
entitled, "Essentials in Pediatric Urology",
"The kidney regulates homeostasis by two fundamental functions, the glomerular and the tubular. In neonates both functions
are deficient and although the neonatal kidneys are well equipped to
sustain physiological processes, they
are severely limited in their response to stress. Neonates have glomerular filtration rate (GFR)
as low as 20ml/min/1.73 m2 at birth, which rises gradually to
reach the adult rates at 18 months. Additionally, due to immature
tubular function, neonates have reduced concentrating capacity, negative
sodium equilibrium and reduced bicarbonate levels and they are, thus, prone to
dehydration and hyponatremia….in a healthy term neonate the GFR at
birth is just 20 ml/min/1.73m and about 10-15 ml/min/1.73m in a premature one.
This low GFR limits all renal functions, especially with regard to water
and electrolyte homeostasis and the excretion of waste products. During the
first month of life GFR increases rapidly due to a rise of systemic BP and a
concomitant fall in renal vascular resistance, but it hardly exceeds
40ml/min/1.73m in the term neonate."13 [emphasis mine]
Taking the
information about neonatal kidney function from the urology text above along
with the information from Figure 2,
a healthy full term infant at birth is
described as having "severely reduced kidney function," and at one
month old, the infant is described as having "moderately reduced kidney
function."13 14
With credible academic and medical sources indicating that infant GFR is equivalent to that of a person with moderate to severely
reduced kidney function, I find it unconscionable that the FDA does not
explicitly warn the public that infants
are in a high-risk category for aluminum accumulation and are therefore not good candidates for any vaccine containing aluminum.
Figure 2. GFR ranges and
associated renal status.
|
Stage 3: moderately reduced kidney
function. (With or without a known kidney disease. For example, an elderly
person with ageing kidneys may have reduced kidney function without a
specific known kidney disease.) |
|
|
Stage 4: severely reduced kidney
function. (With or without known kidney disease.) |
|
|
GFR for premature infants (10-15 ml/min/1.73²) |
How Much is Safe?
Aluminum adjuvant can be found in the
following common childhood vaccines: Infanrix DTaP, Pediarix (DTaP
Let's say your baby weighs around 7lbs at birth. That's roughly 3.25 kilograms. As per the FDA's suggested safe amount of aluminum from parenterals, your 7lb baby could receive up to 16.25mcg parenteral aluminum in one day. According to this product insert for GlaxoSmithKline's Hep B vaccine, the infant dose of ENGERIX (recommended by the CDC to be administered to every infant within hours of birth) contains 0.25 milligrams (mg) of aluminum. Translation: 250 micrograms (mcg). That’s more than 15 times the FDA’s standard of <5mcg/kg/day. Figure 3 shows all CDC recommended vaccine doses containing aluminum between birth and 2 years.
Figure 3.
|
Vaccine |
Time
of Administration |
Aluminum
Content (mcgs) |
Total
Aluminum Count (mcgs) |
|
250 |
|||
|
500 |
|||
|
750 |
|||
|
1,000 |
|||
|
1,250 |
|||
|
1,475 |
|||
|
1,700 |
|||
|
1,925 |
|||
|
2,050 |
|||
|
2,175 |
|||
|
2,300 |
|||
|
2,425 |
|||
|
3,050 |
|||
|
|
3,675 |
||
|
4,300 |
|||
|
4,925 |
Before a child in America turns 2
years old, he/she is looking at a grand total of around 4,925 mcg parenterally administered aluminum from vaccines.
This is a conservative estimate as some variations and combinations of vaccines
contain more aluminum than others. Keeping in mind that many of these vaccines are routinely given at one doctor visit, it is possible that your child could
receive in excess of 1,000mcg parenteral aluminum in
one day.
References:
1. http://www.medilexicon.com/medicaldictionary.php?t=1338
2. http://www.arltma.com/Articles/AlumToxDoc.htm
3. http://www.meerwetenoverfreek.nl/images/stories/Tomljenovic_Shaw-CMC-published.pdf
4. http://medical-dictionary.thefreedictionary.com/parenteral
5. http://emedicine.medscape.com/article/165315-overview
6. http://web.mit.edu/athletics/sportsmedicine/wcrminerals.html
7. http://cshperspectives.cshlp.org/content/3/10/a004259.full
8. http://www.ncbi.nlm.nih.gov/pubmed/11904354
10. http://www.gpo.gov/fdsys/pkg/FR-1998-01-05/pdf/98-76.pdf
11. http://www.fda.gov/OHRMS/DOCKETS/98fr/012600b.txt
12. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3616851/
13. http://www.trnres.com/ebook/uploads/sakellariscontent/T_13605764982%20Sakellaris.pdf
14. http://www.patient.co.uk/health/mild-to-moderate-chronic-kidney-disease
17. https://www.vaccineshoppe.com/image.cfm?doc_id=11169&image_type=product_pdf
20. http://www.merck.com/product/usa/pi_circulars/p/pedvax_hib/pedvax_pi.pdf
21. http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf
22. http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm201669.pdf
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