In September 2010 the Medicines and Healthcare products Regulatory Agency, MHRA, which is the government agency responsible for regulating medicines and medical devices in the UK, reported that there was a risk of aluminium exposure caused by calcium gluconate injection 10% in 10ml glass containers. Calcium Gluconate is licensed for use in certain acute conditions such as hypocalcaemia and cardiac resuscitation. It has been found that Calcium Gluconate solution in glass vials contains almost 200 times more aluminium than Calcium Gluconate in plastic vials; this is due to the solution leeching aluminium from the glass.
Increased aluminium levels can cause aluminium toxicity with adverse effects on bone minerlisation and neurological development, particularly in persons with kidney impairment and children. It is believed that the aluminium leeches from the glass into the solution during autoclaving or storage, although plastic storage vials did not increase aluminium levels. Aluminium levels in glass ampoules of calcium gluconate (in ug/L) in long storage were 6135 and short storage were 4890, these compared with levels in plastic ampoule storage of 31 and 27 respectively; there seemed to be a greater concentration of aluminium in old as compared to new glass vials. It is usual that neonates are fed with parenteral nutrition solutions that have been prepared from Calcium Gluconate injections and so they may have been subjected to unacceptably high levels of aluminium during prolonged feeding periods. Bohrer et al 2003 ( HERE ) note that aluminium release is enhanced from glass ampoules when containing solutions with Calcium and Phosphorus salts. Frey and Maier 2000 found less aluminium contamination in Calcium Gluconate packaged in polyethylene containers (195ug/L) compared to glass vials (5000ug/L).
Why has taken the MHRA so long to report this and what consequences will the MHRA conclusions have on all glass packaging of medicines, foods, and other substances intended for human consumption? The MHRA also confirmed that aluminium might leech from glass by the action of water alone in a glass vial, and that leeching takes place from rubber stoppers at even greater concentrations. For many years now parents have alerted authorities about what they perceived to be serious acute events affecting their children soon after immunisation. Many vaccines are packaged, and stored for long periods, in glass vials with rubber stoppers, and aluminium is a commonly used adjuvant at specific concentrations, the MHRA findings suggest that these concentrations of aluminium may have been heavily contaminated by leeched aluminium at levels which should cause concern.
Examples of vaccine containment include Pluserix vaccine, manufactured by Smith-Kline Rit, SA, gained Product License No. 002/0166 in 1988 under the Medicines Act 1968 and is described on the Part 1 Schedule as being contained in neutral type 1 glass vials with bromobutyl rubber stoppers, aluminium overcaps and flip-off tops, along with the diluent in neutral type 1 glass ampoules or vials with butyl rubber stoppers and aluminium overcaps. Immravax, manufactured by Institut Merieux, received Product Licence No. 6765/0020 in 1989 which describes the vaccine as being contained in single or multidose glass vials. Infanrix, the Hib DTP-IPV vaccine of GlaxoSmithKline uses glass vials. Meningitec manufactured by Wyeth is also stored in glass vials. The recently hyped H1N1 vaccine issued in millions of doses prepared in glass vials each containing 10 individual patient doses; in Chicago alone more than 100,000 persons were inoculated with that vaccine; will Chicago experience an associated increase in mental deterioration as neurological effects take hold amongst that vaccinated group?
The human body has a variety of protective mechanisms to reduce the impact of inhaled and ingested aluminium, a metal not uncommon in our environment and water, such that less than 1% of ingested aluminium is absorbed systemically. However, when aluminium is injected our protective barriers are bypassed and about 40% of intravenous infused aluminium can be retained by adults, up to 75% by neonates, and this can remain in the body for a long time. Aluminium competes with essential trace elements needed for rapid growth and development and can cross the placenta and accumulate in foetal tissue causing in utero death, malformations, delayed ossification and growth, and developmental retardation. Aluminium toxicity can cause metabolic bone disease, anaemia and neurological conditions such as encephalopathy. The US FDA implemented Code of Federal Regulations 2009 stating that large volume parenterals for nutritional feeding cannot contain more than 25ug/L of aluminium, no upper limit was specified for small volume parenterals and the publication states that premature neonates who receive parenteral levels of aluminium greater than 4-5ug/kg/day accumulate aluminium at levels associated with central nervous system and bone toxicity. The MHRA advises that calcium gluconate packed in glass vials should not be used for prolonged or repeated treatment in vulnerable patient groups, particularly those with impaired renal function and pre-term infants.
L. Tomljenovic and C.A.Shaw 2011 (Current Medical Chemistry, 2011, 18, 2630-2637, Aluminium Vaccine Adjuvants: Are they Safe?) state, “Experimental research clearly shows that aluminium adjuvants have a potential to induce serious immunological disorders in humans. In particular aluminium in adjuvant form carries a risk for autoimmunity, long term brain inflammation and associated neurological complications and may have profound and widespread adverse health consequences”. It is doubtful that the issue of additional aluminium leeching from glass storage vials was considered in their study, yet the potential for substantial leeching of aluminium in glass vials containing calcium and phosphorus salts, both commonly used in vaccines and known to increase leeching of aluminium, must now cause concern in light of allegations of vaccine-induced neurological consequences on their children by very many parents. It may be reasonable that medical practitioners accept the use of substances in medical products at levels considered at the time to be safe but it is also reasonable to now expect medical practitioners to seek clarification on the potential contamination of vaccines, and other parenteral products, in light of the MHRA report to prevent their transferring dangerous contaminants into their patients. Such products require exhaustive testing to guarantee child and adult safety. Vaccine manufacturers tend to secure immunity from prosecution for their products, but a medical practitioner may not assume the same immunity in light of the new evidence if they continue to inject aluminium-contaminated vaccines into unsuspecting vaccinees without full disclosure.
According to Tomljenovic and Shaw 2011 infants, newborns and children up to 6 months of age in the US and other developed countries receive 14.7 to 49 times more aluminium than the FDA safety limits from parenteral sources from vaccines through mandatory immunisation programmes. Two month old US, UK, Canadian and Australian children typically receive as much as 220 to 245ug/kg bodyweight of aluminium per vaccine session, a burden equivalent to 34 standard adult dose Hepatitis B vaccine injections. This excludes any additional leeched aluminium from glass vials that the children may unwittingly receive and must pose the question, so often deflected by vaccine manufacturers and their spokespersons, as to how much of the exponential increase in neurological disorders affecting all ages, from the young with autistic spectrum disorders to the older with multiple sclerosis and Alzheimers, plus many other serious debilitating conditions, is caused by the untold burden of aluminium directed past their innate immunity via injectables?
Experiments by Levy et al 1998 (Specificity of an anti-aluminium monoclonal antibody toward free and protein-bound aluminium, J Inorg Biochem, 1998, 69(3), 159-163) suggest that aluminium on its own may act as an antigen therefore raising questions on the possibility that vaccination with aluminium adjuvants may increase an individual’s susceptibility to subsequent exposure to aluminium. Since aluminium is so prevalent in food, water, cosmetics and pharmaceuticals this must cause great concern. Farend et al 1997 (“In vivo absorption of aluminium-containing vaccine adjuvants using 26Al”, Vaccine, 1997, 15(12-13), 1314-1318) estimated aluminium absorption in adult female rabbits following intramuscular injection of two forms of Al labelled adjuvants, aluminium hydroxide and aluminium phosphate, and results showed both were rapidly absorbed, appearing in the blood as rapidly as one hour after injection. Blood levels remained elevated for 28 days post injection in both cases and tissue analyses showed elevated levels of aluminium in kidney, spleen, liver, heart, lymph nodes and brain albeit the levels in the brain were lower than in the other organs. However, Yumoto et al 2000 (“Transplacental passage of Al from pregnant rats to foetuses and Al transfer through maternal milk to suckling rats”, Nucl Instrum Methods Phys Res B, 2000, 172(1-4), 925-929) indicated that such tissue distribution might be age-dependent. Aluminium injected into pregnant rats was transplacentally transferred to the foetuses and was found to be 30% higher in the foetal brain that in the liver, while in their mothers’ brains there was only 1% the amount of aluminium found in their livers, suggesting that a foetal brain may act as a sink for aluminium. Mothers to be are regularly vaccinated with aluminium adjuvant vaccines such as anti-tetanus, Hepatitis A and B, Meningococcal and Pneumococcal in the US.
Numerous serious side effects have been reported as potentially caused by aluminium adjuvant containing vaccines, not least macrophagic myofasciitis (MMF) amongst recipients of Hepatitis A and B vaccines, cases which may involve diffuse arthromyalgias, chronic fatigue, muscle weakness and multiple sclerosis (Gherardi et al 2001,1998, 2006). The presence of serum autoantibodies and evidence of increased inflammation was seen in lab tests of MMF subjects, with the inflammation demonstrated through the increases in inflammatory cytokines interleukin-1 receptor antagonist and IL-6 (Eickhoff et al 2002 “Workshop Summary, Aluminium in vaccines”, Vaccine 2002, 20 Suppl 3, S1-4)). Do these findings have an echo in the recent discovery of unusual levels of IL-6 amongst the brains of autistic subjects, specifically the cerebellum, indicating inflammatory activity that could explain some of the common characteristics experienced by those suffering autistic spectrum disorders. Observers with expertise in the chemistry of mercury and other toxic materials used in vaccines consider mercury in its vaccine form, ethyl mercury as part of thimerosal adjuvant, as a probable cause of ASD, and also aluminium both singly and in combination with mercury since they create a toxic blend which can be more dangerous than either metal singly. It seems highly plausible, if not inevitable in the more susceptible recipients, that the direct insertion of toxic metals into the blood bypassing all major effective protective systems the body can harness, at levels far exceeding those deemed safe by the US EPA and FDA, will cause serious toxic events including death and severe neurological debility.
The question is not do such vaccine constituents cause side effects in children, as this ought to be an expectation for most recipients when vaccine concentrations far exceed safety levels, but why do they not cause serious side effects in some children? If expectations were that most children would succumb in some way to these dangerous toxins, injected at exceptional concentrations directly into the blood and muscle, what events would be expected? For both mercury and aluminium common events would be death and severe neurological deficit, both of which are alleged by parents to occur at exceptional levels in their so-called vaccine damaged children. Studies in Africa by Aaby et al over several years demonstrated increases in death rates among children receiving DTP, a vaccine known to contain mercury and aluminium, above the norm and even deaths for which there was a gender skewing in favour of more girls dying than boys at certain titres; they also reported that increased death rates could be mitigated by slight alterations to the vaccine schedule. Although the scientists who made these discoveries are fairly certain of their data, the WHO continues to deny what may turn out to be issues not only of mortality caused by vaccines but – through that denial and continuation of potentially fatal vaccine practices in the developing world – the unlawful killing and maiming of many children by vaccination; yet it is known that monies can be better spent on the provision of clean plentiful water, sound nutrition, and sanitation which reduced the impact of diseases to almost negligible in a matter of months of application in the developed world. Unfortunately for the developing world children there is little or no profit in providing them with sanitation and clean water, there are enormous profits in vaccination both by direct marketing and, perhaps most lucratively, via the global charity-route.
If this news from the UK MHRA is insufficient to engender a national wake-up call then surely the news that some 43% of American children, perhaps the most vaccinated on the planet, were found to suffer from at least 1 of 20 chronic health conditions in a study by Christina D. Bethell et al 2010, excluding obesity and being at risk of developmental delays, or if the latter were included, the percentage of American children suffering at least one chronic disease is 54%, an unbelievably high proportion of any developed society, and one about which every American parent and prospective parent ought to be extremely concerned.
John Heptonstall is an Honours Graduate in Applied Science (Maths, Physics, Biology), has a Doctorate in Natural Medicines, is a Specialist in Traditional Chinese Medicine of almost three decades practice, and has a 28 year old son with Classic Autism.