Vaccine ingredients Adjuvants.

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The 'witches brew' analogy is carried into some respected science

journals. The New Scientist1 in 1996 published an article called Dirty Secrets.

It referred to adjuvants in vaccines as " a nonspecific mix of some very weird

ingredients " . It went on to say " this eye of newt, toe of frog approach to

vaccine design makes some immunologists uneasy " . The article claimed that

immunologists knew as much about witches' spells as they did about how adjuvants

worked.

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 , 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, Kline 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- 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.

I have read the main articles/books listed below but not the articles

cited from within the book.

1. Brown, P. Dirty Secrets. New Scientist, 2 November 1996, pp26-29.

2. BioTech's Life Science Dictionary Search for 'adjuvant'.

3. Flarend E, Hem S, White J, et al. In vivo absorption of

aluminium-containing vaccine adjuvants using 26Al. Vaccine 1997, Vol 15, No

12/13, pp1314-1318. Press story

4. Flarend, R. and Elmore, D. Aluminium-26 as a Biological Tracer using

Accelerator Mass Spectrometry. In: Zatta PF, Alfrey AC. (Eds) Aluminium Toxicity

in Infants' Health and Disease. 1997, World Scientific Publishing.

5. McGraw, ME. Aluminium Toxicity in Infants. In: Zatta PF, Alfrey AC.

(Eds) Aluminium Toxicity in Infants' Health and Disease. 1997, World Scientific

Publishing. Quoting studies by:

Simmer, K. Aluminium and Infants. Journal of Paediatrics and Child

Health, 1993, 29(2), p80-81. No abstract available.

Tsou, VM., Young, RM., Hart, MH., Vanderhoof, JA. Elevated plasma

aluminium levels in normal infants receiving antacids containing aluminium.

Pediatrics, 1991, 87(2), p148-151.

6. Simmer, K. Aluminium in Infancy. In: Zatta PF, Alfrey AC. (Eds)

Aluminium Toxicity in Infants' Health and Disease. 1997, World Scientific

Publishing. Quoting studies:

Chedid, F., Fudge, A. et al. Aluminium absorption in infancy. Journal

of Paediatrics and Child Health, 27 (1991) pp 164-166.

Woodard-Knight, L., Fudge, A. et al. Aluminium absorption and antacid

therapy in infancy. Journal of Paediatrics and Child Health. 1992, 28(3), pp

257-259.

7. AAP Policy Statement Aluminium Toxicity in Infants and Children.

8. Aluminium: Report of an international meeting 268KB pdf document.

9. Simmer, K. Aluminium in Infancy. In: Zatta PF, Alfrey AC. (Eds)

Aluminium Toxicity in Infants' Health and Disease. 1997, World Scientific

Publishing.

10. General Biological Products Standards

11. Flarend, R. and Elmore, D. Aluminium-26 as a Biological Tracer using

Accelerator Mass Spectrometry. In: Zatta PF, Alfrey AC. (Eds) Aluminium Toxicity

in Infants' Health and Disease. 1997, World Scientific Publishing. Citing:

A. C. Alfrey, in Aluminium and Health: A critical review. ed H. J.

Gitelman (Marcel Dekker, New York, 1989), pp. 101-124.

12. Goto, N. Toxicity of Aluminium Compounds as an Adjuvant for Vaccines.

In: Zatta PF, Alfrey AC. (Eds) Aluminium Toxicity in Infants' Health and

Disease. 1997, World Scientific Publishing. Citing the following studies:

a. Goto, N and Akama, K. Histopathological studies of reactions in mice

injected with aluminum-adsorbed tetanus toxoid. Microbiol. Immunol. 1982,

26(12), p1121-32.

b. NR, Voyce MA, et al. Advantages of aluminium hydroxide adsorbed

combined diphtheria, tetanus, and pertussis vaccines for the immunization of

infants. British Medical Journal, 1969, 1(645) p 663-666. (No abstract

available)

c. Vassilev TL. Allergy, Aluminium phosphate but not calcium phosphate

stimulates the specific IgE response in guinea pigs to tetanus toxoid. 1978,

33(3), p 155-159

Bohler-Sommeregger K and Lindemayr H. Contact sensitivity to

aluminium. Contact Dermatitis. 1986, 15(5), p 278-81.

Veien NK, Hattel O, et al. Aluminium Allergy. Contact Dermatitis.

1985, 15(5), p 295-297.

d. Someya S, Mizuhara H. Studies on the adequate composition of

diphtheria and tetanus toxoids-with reference to the amounts of toxoids and

aluminum adjuvant. Jpn. J. Med. Sci. Biol. 1981, 34(1), p 21-35.

e. Goto N, Kato H. Studies on the toxicities of aluminium hydroxide and

calcium phosphate as immunological adjuvants for vaccines.Vaccine. 1993, 11(9),

p 914-918.

13. Malakoff, D. Aluminium is put on trial as a vaccine booster. Science,

2000, May 26, Vol 288, pp1323-1324.

Gherardi R, Coquet M. Macrophagic myofasciitis: an emerging entity. The

Lancet, 1998, August 1, 352(9125), pp347-352.

Gherardi R, Coquet M. et al Macrophagic myofasciitis lesions assess

long-term persistence of vaccine-derived aluminium hydroxide in muscle. Brain,

2001, 124(9), pp1821-1831.

What is a macrophage?

Adjuvants | Cell Lines |

Updated: 28 Aug, 2001

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