Aluminum Vaccine Adjuvants: Are they Safe?

by L. Tomljenovic and C.A. Shaw, 2011

Tomljenovic_Shaw-CMC-Full PDF


During the course of the last 30 years, the number of officially scheduled vaccines deemed necessary for children in the U.S. has increased sharply, from 10 in the 1980’s to 32 in the last 2000s, 18 of which contain aluminum adjuvants. The issue of vaccine safety thus becomes even more pertinent given that, to the best of our knowledge, no adequate clinical studies have been conducted to establish the safety of concomitant administration of two experimentally-established neuro-toxins, aluminum and mercury.

While direct application of aluminum adjuvants to the central nervous system (CNS) is unquestionably neurotoxic, little is known about  aluminum transport into and out of the CNS, its toxicokinetics, and the impact on different neuronal sub-populations following subcutaneous and intramuscular injections. The reason for this is that under current regulatory policies, evaluation of pharmacokinetic properties is not required for vaccines. This issue is of special concern in context to worldwide mass immunization practices involving children whose nervous systems are undergoing rapid development.

Furthermore, an immature developing blood brain barrier (BBB) is more permeable to toxic substances than that of an adult. In addition, there are critical periods in neuro-development that occur within the first few years of postnatal life during which exposure to neurotoxic insults may induce CNS damage. In that respect, it is worth noting that any potential CNS damage caused by aluminum in children may not be evident until a later stage of development.

…newborns, infants, and children up to 6 months of age in the U.S. and other developed countries receive 14.7 to 49 times more  than the FDA safety limits for aluminum from parenteral sources from vaccines through mandatory immunization programs.

…parenterally administered aluminum bears more relevance to vaccine exposure than dietary aluminum…unlike dietary aluminum of which only -.25% is absorbed into systemic circulation, aluminum from vaccines  is absorbed at nearly 100% efficiency.

The possibility that the fetal brain may act as a sink for aluminum may be of concern since under certain circumstances, vaccination of pregnant women with a number of aluminum-adjuvanted  vaccines (tetanus, hepatitis A and B, meningococcal and pneumococcal) is recommended under the current U.S. immunization guidelines.

A recently described syndrome termed macrophagic myofascitis (MMF) has been specifically attributed to aluminum vaccines.  MMF patients were found to suffer from diffuse arthromyalgias, chronic fatigue, muscle weakness and in some cases, multiple sclerosis…Aluminum was shown to persist at the site of injection from several months up to 8 years following vaccination.  MMF lesions were subsequently also reproduced in rates by injection of aluminum adjuvants. 

Dr. Gherardi who first described MMF noted: “It is plausible that persistent systemic immune activation that fails to switch off represents the pathophysiologic basis of chronic fatigue syndrome associated with macrophagic myofascitis, similarly to what happens to patients with post-infectious chronic fatigue and possibly idiopathic chronic fatigue syndrome.”The symptoms of MMF are similar to those of GWS (Gulf War Syndrome), a multisystem disorder which has been linked to multiple vaccinations administered over a short period of time. As with autism and MMF, GWS patients also show Th2 predominance and a significant risk factor in causing this syndrome may be  aluminum hydroxide adjuvant from the anthrax vaccine. Injections of aluminum hydroxide at levels comparable to those administered to Gulf War Veterans, were shown to cause significant motor neuron degeneration as well as impairment in motor function and decrements in spatial memory capacity in young male mice.

Of even graver concern is that persistent Th2 stimulation, due to repeated administration of aluminum-adjuvanted vaccines, may have profound long-term adverse effects on the developing immune system in children.  A newborn infant has an undeveloped immune system which is limited in function and requires a series of challenges to bring it to full capacity. Prior to introduction of mandatory vaccines, these challenges were largely in the forms of relatively mino9r childhood diseases such as mumps and measles.  Vaccinations targeted at stimulating antibody production by the humoral immune system (Th2) located in the bone marrow, bypass the cellular immune system (Th1) on mucosal surfaces (respiratory and gastrointestinal tract), leaving the latter unchallenged during the critical period of development. Since Th1 progenitors will not differentiate into Th1 cells in the absence of Th1-cytokines (due to chronic stimulation of the Th2 pathway), the end result of a prolonged Th2 shift may be permanently stunted cellular (Th1) immunity. Ironically, Th1 immunity is inherently far more efficient in clearing viral pathogens than Th2 immunity, which further raises a question about the general efficacy of alulminum-adjuvanted vaccines in fighting viral infection.

...Permanent activation of brain inflammatory responses has long been recognized as a factor in etiology of many neurodegenerative diseases, including Alzheimer’s disease, autism, multiple sclerosis and dialysis dementia. Notably, all of these diseases have been previously linked to aluminum exposure. Aluminum potentiates inflammatory responses in teh brain by multiplemechnisms, such as activation of micoglia and induction of pr0-inflammatory gene expression.

…Aluminum in various forms can be toxic to the nervous system.  The widespread presence in the human environment may underlie a number of CNS disorders.  The continued use of alulminum adjuvants in various vaccines for children as well as the general public may be of significant concern. In particular , aluminum presented in this form carries a risk for autoimmunity, long term brain inflammation and associated neurological complications and brain inflammation and assocciated neurological complications and may thus have profound and wiespread adverse health consequences. The widely accepted notion of aluminum adjuvant safety does not appear to be firmly established in the scientific literature and, as such, this absence may have laead to an erroneous conclusions regarding the significance of these compounds in the etiologies of many common neurologiccal disorders. Furthermore, the continued use of aluminum-containing placebos in vaccine clinical trials may have lead to an understimation of the true rate of adverse outcomes associated with with aluminum-adjuvanted vaccines.

In our opinion, a comprehensive evaluation of the overall impact of aluminum on human health is overdue. Such an evaluation should include studies designed to determine the short and long-term impacts of dietary aluminum as well as the potential impacts in different age groups of exposure to adjuvant aluminum alone and in combination with other potentially toxic vaccine constituents (e.g., formaldehyde, formalin, mercury, phenoxyethanol, phenol, sodium borate, polysorbate 80, glutaraldehyde).  For the latter, until vaccine safety canbe comprehensively demonstrated by controlled independent long-term studies that examine the impact on the nervous system in detail, many of those already vaccinated as well as those currently receiving injections may be at risk for health complications that exceed the potential benefits that vaccine prophylaxis may prov ide. The issue of aluminum adjuvanted vaccine safety is especially pertinent in light of the legislation which might mandate vaccination regimes for civilian populations (e.e., the Bio-defense and Pandemic Vaccine and Drug Development Act of 2005). Whether the risk of protection from a dreaded disease outweighs the risk of toxicity from its presumed prophylactic agent is a question that demands far more rigorous scrutiny than has been provided to date.