The shocking truth about aluminium (aluminum) in vaccines from UK government documents
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.