http://vaxchoice.crosswinds.net/vaccination/adjuvant.html
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So what are adjuvants and how do they work? BioTech's Life Science
Dictionary2
defines an adjuvant as: "In immunology, a substance
that is added to a vaccine to improve the immune response so that less
vaccine is needed to produce more antibodies. Such adjuvants apparently work
by speeding the division of lymphocytes and by keeping the antigen in the
area where the immune response is taking place. In research with humans,
aluminum phosphate and aluminum hydroxide gel are commonly used; in research
involving lab animals, Freund's adjuvant is used." The adjuvant, usually aluminium hydroxide, binds the
antigen to its surface in a process known as 'adsorption'. Once injected
aluminium compounds are believed to form a depot at the site of the injection
and slowly release the antigen. The 'depot' theory has been called into doubt
by at least one study3. The
study, conducted on rabbits, demonstrated that the aluminium begins to dissolve
almost immediately after injection and is eliminated from the body hundreds
of times faster than previously thought. Prior to 1990 it was not possible to follow the path of aluminium through
the body. However the development of a new technique, accelerator mass
spectrometry (AMS), has meant that it is now possible to inject aluminium and
observe how it is metabolised by the body. The aluminium used is isotope 26Al,
a radioactive substance with a half-life of 730,000 years. Radiation exposure
is neglible as very small amounts of the isotope are used. The first study
using AMS, on rats, was published in 1990. [4] Aluminium is the most abundant metal and the third most abundant element
on earth. We are constantly exposed to aluminium in our food and water
supplies. An infant is exposed through breastmilk, formula milk (especially
soy-based) and antacids. In one Australian study it was found that 13% of
healthy infants aged 1-6 months may have received antacids. [5] Studies have
shown that some infants receiving antacids had elevated plasma levels and
urinary excretion of aluminium. It was also discovered that it was not
possible to predict which child would develop high plasma aluminium levels
using dosage or age as predictors. [6] Aluminium is a known toxin which can cause encephalitis, bone disease and
anaemia in susceptible people7 8.
Toxicity levels have been determined using values for adults and older
children with renal disease, with plasma levels greater than 3.7 umol/L
considered toxic. The kidneys eliminate aluminium from the body and so people
with renal problems are at risk of aluminium toxicity. However all infants
have reduced renal function and so may not be able to effectively excrete
excessive aluminium. Kidney function (glomerular filtration rate) is low at
birth and reaches adult level by 1-2 years of age. [9] The Hepatitis
B vaccine, which is given immediately after birth, contains aluminium
hydroxide as an adjuvant, the amount of which will depend on the
manufacturer. In Australia the vaccine contains 0.5 mg/ml and the dosage given
is 0.5 ml for children and 1 ml for adults. The maximum amount of aluminium present in a single vaccine dose is
limited by the FDA to 0.85 - 1.25 mgms, depending on the method of
measurement10.
The normal plasma level of aluminium is 5 mcg/L and the normal vaccine
concentration of 0.85 mgms/dose results in plasma concentration increasing by
0.02 mcg/L. For this reason aluminium adjuvants are currently considered an
insignificant source of aluminium and not of toxicological interest. [11] Goto12
presents an article detailing current knowledge about the toxicity of
aluminium compounds. It is worth noting that the vast majority of the
references cited by Goto are pre-1985. Many of the articles I have read for
this page have commented on the lack of data and paucity of studies. Given
the widespread use of aluminium adjuvant vaccines this is not acceptable.
Infants receive aluminium containing vaccines from birth and it is not asking
too much that the safety and long term consequences of periodic exposure to
aluminium is investigated thoroughly. Many of the studies conducted have been
on rodents for the obvious reason that taking tissue biopsies, and worse,
from infants would be highly unethical. The presence of aluminium in a vaccine can cause small nodules to develop
under the skin of some people. These nodules are usually transient in nature
and disappear spontaneously after a few weeks. In rare cases extreme
hypersensitivity to aluminium results in persistent nodules. One study12a
(in mice) suggested that the nodules were related to an interaction between
tetanus toxoid preparations and the aluminium compound, rather than just the
aluminium. The adjuvant is also responsible for a high incidence of local
reactions, such as redness, pain, swelling, sterile abscess, and induration12b.
Early studies also suggested a relationship between aluminium compounds and
an increased incidence of allergic diseases12c. Goto also reports on unsolved problems regarding the preferred route of
administration for aluminium adjuvanted vaccines. One study reports less
reactions using the subcutaneous12b
(SC) route whereas another says the intramuscular12d
(IM) route is the less reactogenic. On the basis of animal studies Goto
concludes that SC is probably preferable to IM, particularly for tetanus
toxoid vaccines, despite the more severe local reactions. Goto says that "there is general consensus
that adjuvants with less toxicity must be found for practical purposes" and that "This prospect of repeated
injections [of aluminium adjuvanted vaccines] raises important questions in
light of the present study12e
[on guinea pigs] that revealed long-term depostion of adjuvant at the
injection site and, possibly, local reactions augmented by the interaction of
adjuvant and vaccine." During May 2000 in San Juan, Peurto Rico, there was a
workshop on aluminium in vaccines. The delegates discussed the findings of a
Dr Gherardi, a pathologist who had a theory about a new condition. He had
discovered macrophages in the muscles of people complaining of fatigue and
sore muscles. He called the condition Macrophagic Myofasciitis (MMF). It was
later discovered that the macrophages were filled with aluminium. At the
workshop the researchers agreed that it was aluminium and that the source was
vaccines. However there was insufficient evidence to say that vaccines caused
MMF and there is doubt over whether MMF is a new condition. The findings have
pushed aluminium onto the research agenda and clinical studies are planned: A
large trial on the safety of the anthrax vaccine could also look at the
aluminium issue, SmithKline Beecham (SKB) are studying the biological impact
of aluminium on animals and other studies are being considered. [13.] Vaccine researchers see similarities between the current aluminium
'problem' and thiomersal. Thiomersal, a mercury compound, is to be eliminated
from vaccines due to safety concerns. The Science article says "...many researchers felt
hamstrung by a lack of data on everything from mercury's interaction with
other vaccine compounds to acceptable doses for infants." Alison Mawle, a researcher with the CDC, is quoted as
saying "There are huge gaps in
what we know about the toxicity of aluminium." Manufacturers are not keen to replace aluminium as it
would "costly and complicated" to come up with an alternative and
the regulatory and manufacturing requirements would be a
"nightmare", according to Nathalie Garcon-Johnson of SKB. The panel
drafting the workshop's summary statement were urged, by Dr Vito Caserta (US
Division of Vaccine Injury Compensation), to "tread cautiously" as
'anti-immunization' groups had already identified aluminium as a "cause
for concern" and that "courts don't know how to deal with
[uncertainty about] causality". [13] Several vaccines contain aluminium adjuvants: DTaP, DTP, DTP-Hib, Hep B,
Hep B-Hib, Tetanus. The amount of aluminium varies between vaccines and
ranges from 0.7-5.1 mg over a complete series. The higher value is for
tetanus only vaccines, the DTaP has from 0.9-3.1 mg, for the complete series,
depending on manufacturer. [13] It appears that studies are underway, or in
the pipeline, to determine the effects of aluminium on infants and children.
However it is also apparent that the manufacturers, and researchers, do not
want to hear bad news. Given that Hepatitis B vaccine, which contains
aluminium hydroxide, is now routinely given to newborn infants the studies
are long overdue. Adjuvants | Cell Lines
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