Aluminium, Vaccines, Nanoparticles, Polysorbate and Toxicity

With the current COVID19 coronavirus pandemic that has engulfed almost the entire globe, the public health crisis has aroused concern and care for vaccines at a level never previously seen. Along with that, there has appeared the Covid-deniers who mostly coincide with the usual anti-vaccination personalities, spreading  concepts that are entirely entertainment for science-fiction movies with their typical dogma of re-packaged doubts that they portray as scientific. Moreso there has appeared conspiracy theories from these same sorts of people, many of them opposing nearly every single government around the world that has introduced infectious control measures to reduce transmission. Even from Islamic perspective they believe all of the Islamic scholars together have been duped into this vague conspiracy and plot. This in itself is enough as a refutation against them.

Discussing vaccines is not an easy task as it’s very easy for anyone to throw in doubts against them however to dispel them very same doubts requires to dive into deep scientific concepts and studies of evidence that is very time and effort consuming and often difficult to understand by the non-scientific community. Likewise it needs skills to distinguish between good and bad studies in terms of the quality of the study. Thus when I’m in my clinical practice chair and a patient or parent declines a vaccine, I will often answer the choice is theirs but against my advice without getting into details, otherwise could sit for hours dispelling each and every myth. The reason why the myths are many is that the anti-vaccine lobby has continously moved its goal posts with their initial emphasis on having multiple vaccines together  (like triple MMR) as being the criminal particularly for autism. When that was refuted they incriminated thiomersal, then later switched to incriminating formaldehyde and in recent years they have switched to the incrimination of aluminum and now its specifically nanoparticles of aluminium. In a few years time it will switch to something else being the toxic agent.

Countries that mandate vaccination for entry into schools like in the US tend to have a larger anti-vaccination lobby than compared in the UK where it is voluntary, which I favour in giving a higher uptake. During the current COVID19 pandemic this latter point might become more predominant as the principles of vaccination is built upon the concept of herd immunity for it to be effective. There is evidence for the unvaccinated posing a risk to everyone such as what happened with measles outbreaks in the UK & US which was a clear result of poor vaccine uptake after have been eliminated for some years with previous good vaccine uptake. This is also the case with delayed vaccines and vaccines done out of sequence.

Aluminium

Aluminium, Al, has no known biological or physiological function in our bodies. It is the most common metallic element on earth, present in the food we eat, the water we drink and the air we breathe. Babies are born with aluminium in their bodies and receive more through their feeds of breast milk and formula. Several medicines especially some antacids contain aluminium. Cosmetics and antiperspirants likewise add to our aluminium accumulation. Aluminium is found in tobacco and cannabis with both active and passive smoking leading to inhaled aluminium.

Aluminum nanoparticles (2–3 nm diameter) are used in pigments and cosmetics, fine polishing powders and in microelectronics production. Aluminium nanoparticles are generated during friction stir, flame and solid-state welding and smelter emissions (from anode baking furnace exhaust, potroom scrubber stacks, and potroom roof vents) and can be inhaled. Furthermore volcanic ash leaves aluminium nanoparticles suspended in ambient air.

Aluminium absorption

The total daily aluminium consumption varies by location being estimated for UK at 71μg/kg and 187μg/kg in adults and children respectively, while comparing this to Canada at 56μg/kg and 64μg/kg respectively, yet for the US its around 122 μg/kg for adults. However absorption into our bodies is low at about 0.1% for solid food and up to 0.3% if watery via the gastrointestinal barrier while about 1.5% through air borne soluble particles via the nasal cavity.
A detailed estimated breakdown for US population of aluminium by Yodel et al is summarised in Table 1 below:

Comparison and sources for the amount of aluminum exposure summarised table.The main point is the absorbed amounts into the body (the last column in the table) from infant vaccination schedule is marginally less than absorbed amounts from daily food.  More importantly it is far, far less than other sources such as daily industrial exposure, dialysis solutions, antacids and intravenous feeding  (parenteral nutrition, PN) especially in infants. The aluminium absorption from infant vaccine schedule is between 0.07 and 0.4 μg/kg daily. What we really want to know is, how much of an effect this has on aluminium blood concentration, which we will discuss in the next section.

Aluminium blood level & Toxicity

Nearly all (98%) of the aluminium is removed by the kidneys with the rest removed via bile mostly. Hence kidney function impairment (which is very frequently the case in premature neonates) is a risk for accumulation. Accumulation and overload is also a problem with hundreds of other substances that are also excreted by the kidneys like potassium, calcium, etc. Like these other minerals and salts, aluminium overload is toxic being associated with encephalopathy (brain disease), neurological development impairment, metabolic bone disease, anaemia, lung damage and more. However association does not mean causation and more needs to be done to establish the latter especially in Alzheimer’s disease where other accumulations are also seen. 

Given that aluminium is so prevalent in our environments, thankfully our bodies are wonderfully designed to remove it effectively and unless we are getting very large amounts directly into the bloodstream or with the high chronic occupational levels (which can lead to the lung illess, pneumoconiosis).  Aluminium overload causing toxicity, especially neurotoxicity that affects the brain function, has been recognised for decades before the anti-vaccine lobby incriminated it as a problem. A study by Alfrey et al from 1976 demonstrated a 10-fold increase in brain aluminum concentrations was reported in postmortem adults who suffered aluminum neurotoxicity (encephalopathy) through the use of dialysis solutions with high levels of aluminum. In addition a study by Bishop et al in 1997 demonstrated premature neonate babies developing neurological impairment when their intravenous feed (parenteral nutrition, PN) that contained higher amounts of aluminium (median: 45 mg/kg/day compared to 4-5 mg/kg/day for a period of 5–16 days) had worse mental development when assessed at 18 months. Furthermore a 15 year follow-up study demonstrated that the higher aluminium group had thinner bones at the hip (with a lower bone mineral content).  

Blood concentrations with serum aluminium over 30 μg/L in dialysis patients has been associated with bone thinning (osteomalacia and related disorders) while over 80 μg/L has been associated with in some to cause early neurotoxicity of the brain (including encephalopathy) and usually needs to be over 200μg/L.  Comparing these numbers to the normal background aluminium blood serum concentration range which is around 2.7 to 6.2 μg/L, we would need increases in blood levels of about 400% for toxicity and about 1200% increase for early effects of neurotoxicity.  When aluminium overload occurs then a binder medicine (a chelator like desferrioxamine) which locks on to the aluminium in our blood stream in order to soak up the aluminium then remove it from the body is used. Death by aluminium toxicity nowadays is extremely, extremely rare.

Aluminium adjuvants in vaccines

Many vaccines contain a tiny bit of aluminium (between 0.15 and 0.85mg of elemental aluminium) in the form of a salt, mainly aluminium hydroxide and a few contain aluminium phosphate, to enhance the immune response. The quantity of elemental aluminium is tiny compared to the regular exposure we have over our life time and even minuscule compared to parental nutrition, PN (IV feeding) that very premature neonatal babies receive over the  first few weeks and months of life when it’s needed. More so the vast majority of children that vaccines are given to generally have normal kidney function and a fully developed blood brain barrier, BBB,  unlike in premature neonates. This fact in itself should be sufficient to reassure most parents against the doubts of the anti-vaccine lobby.  Furthermore aluminum salt particles in vaccines tend to mostly remain localized at the muscle of injection site (and NOT injected into bloodstream, as is the case with PN and dialysis components) and get absorbed very slowly into the blood stream further reducing the daily dose into the blood stream.  Yet the anti-vaccine lobby continues to bring new doubts against their usuage.

Palevsky

Dr. Lawrence (Larry) Palevsky, an “integrative” paediatrician, who was an “expert” for the anti-vaccination movie The Greater Good and has links to and quotes other anti-vaccine personalities. As a promoter of the anti-vaccine lobby, he has been vocal recently to a non-scientific audience and this as usual has spread on social media. It was brought to my attention for comment. My initial thoughts were the doctor is very articulate and maybe presuassive if you have a non-scientific background, however with a little scientific and clinical knowledge then his assertion at best are ignorance and at worse fictitious. His general assertion is:  vaccines contain aluminum nanoparticles, aluminium nanoparticles cross the BBB, aluminum is neurotoxic, and therefore vaccines containing aluminium are neurotoxic. Further he asserts that polysorbate 80 which is present in some vaccines, damages the BBB while also carrying these aluminium nanoparticles across the BBB. Let us deconstruct this and some of his other assertions to see his reality.

No studies argument

Dr. Palvesky claims (quote): “You cannot find a single study in the literature that addresses whether the injection of aluminum into the body penetrates the brain, whether any vaccine ingredients enters the brain, and whether polysorbate 80 enhances the delivery of any of those ingredients into the brain.” (end of quote) …. Yet at the same time he contradictingly claims, that these vaccine adjuvants get into the brain causing inflammation and damage while polysorbate 80 damages the BBB (blood brain barrier). So if there aren’t any studies as per his assertion then how did he arrive at his other assertion that they damage BBB and enter the brain. If it wasn’t by way of a scientific study then either it was divinely inspired or its been fictitiously imagined!
Well the reality is there are studies, but when someone paints a picture claiming otherwise, they just really demonstrating their lack of research ability and ignorance at best, or at worse being fictitious. If they’re contradictory in that then this would point to the latter, rather than the former.

Not only are studies present, but there have also been frequent systematic reviews that give updates of those multitude of studies by many different authors. Such as:

Systematic review of potential health risks posed by pharmaceutical, occupational and consumer exposures to metallic and nanoscale aluminum, aluminum oxides, aluminum hydroxide and its soluble salts.

Willhite et al. Critical reviews in toxicology vol. 44 Suppl 4,Suppl 4 (2014): 1-80. doi:10.3109/10408444.2014.934439

Within this systematic review by Willhite et al are present dozens of studies summarised, many of which include both toxicity and more so neurotoxicty in both adults and infants. Furthermore there are many more studies in animals, even to the extent that aluminium is directly injected into the brain (intracerebral) of rabbits and in other studies, radio-labelled aluminium injections are monitored to see how they move around the body for over 12 months, etc. These types of studies would raise ethical issues if carried out in humans due to the harms of radioactivity over such a prolonged period and hence are done in animals instead. In summary, this systematic review indicates the risks of aluminium involves high doses like intravenous feeding/PN especially in premature babies, secondly in some dialysis solutions previously used in kidney failure and thirdly in chronic occupational airborne particles.

To give an example, this above review discusses a study by Flarend et al that looked at the absorption from two different types of aluminium salts, aluminium hydroxide and aluminium phosphate, that are used in vaccine adjuvants and how they’re absorbed, taken up by different organs (including the brain) and eliminated from the body of rabbits with radioactive labelled aluminium.  They found the absorption to be very slow taking almost 6 months to clear aluminium from the muscle injection site, with only 17% absorbed at 28 days (giving an average bioavailability of 0.6% daily) for aluminium hydroxide. They also found that the aluminium dose associated with a single adjuvant muscular injection represented at most an 0.8% increase above the baseline blood aluminum level. This 0.8% increase is no where near the high levels required to cause toxicity (where 400% increase is needed) and even further away from the extreme levels needed (of at least 1200% increase) to induce neurotoxicity.

Aluminium nanoparticle adjuvants

Nanomaterials and nanotechnology refers to tiny materials having a length scale in the range of 1 nanometer, nm, upto 100 nm in at least one dimension. The aluminum salts used as an adjuvant in vaccines to date in clinical practice are not nanoparticles as claimed by Dr. Palvesky but rather are a much larger size in the range between 1-10 micrometers, μm, in diameter with a median diameter of around 3 μm. This is because they are present as salts like aluminium hydroxide or aluminium phosphate and clump together to form particles. Even the newer (MF59 and AS04) adjuvent systems in some vaccines are regarded as microparticles which are greater than 100nm. Hence they are microparticles and not nanoparticles. This is explained in detail in a book entitled “Micro- and Nanotechnology in Vaccine Development“. It discusses how elemental aluminum and other particles are adsorbed onto or encapsulated as nanoparticles as potential medicines and potential vaccines and are currently undergoing experimental testing in the lab still. That nanoparticle adjuvants work with completelely different mechanisms to the current adjuvants and none are used in clinical practice settings or available commercially.
Hence this buzzword of nanoparticles is to spread doubts and confusion that current vaccines are untested to a non-scientific audience, who would not be prepared for such absurdness.

Aluminium crossing the blood brain barrier, BBB

The only real direct way to investigate which types of aluminium cross the BBB is to use radioactive labeling and then monitor by scanning. Doing such a trial in humans raises all kinds of ethical issues due to the risk of causing brain damage and brain cancer. Hence Wiesnieski et al investigated the effect of aluminium chloride, aluminium lactate and aluminium hydroxide on rats’ BBB using radioactive sucrose to follow changes in the barrier integrity. They noted an increase in BBB leakage at two and four hours after administration but did not show any differences after 24 hours (this indicates it’s dose related and leakage occurs as the aluminium levels peak). More importantly, aluminium chloride and aluminium lactate caused this leakage whereas aluminium hydroxide showed no effect on the BBB. From these three salts, only aluminium hydroxide is used in vaccines. This study demonstrates that aluminium hydroxide does not cross the BBB nor induces BBB breakdown at the level used in vaccines. Obviously aluminium can cross the BBB but needs much higher concentrations in the blood than amounts in vaccines to cause any inflammation or damage.

Most elemental metals including aluminium (irrespective of its source, including from food) can dissociate into ionic forms in water (of the bloodstream) into Al3+ which is the size of picoparticles (i.e. even smaller than nanoparticles) which makes the whole buzzword of nanoparticles rather more bizarre. However they can’t cross the BBB due to the ionic charge (3+). The solubility of aluminium hydroxide is relatively low so needs a very large amount of it to dissolve out compared to other alumnium salts like the chloride. This factor explains why in this aforementioned study the aluminium hydroxide was different to the other two types of aluminium salts studied.

More importantly extremely high aluminium from the diet can likewise cross the BBB as established by mice consuming a diet increased several folds from 1 week of age. The crucial point is the amount entering the bloodstream needs to be extremely high to achieve this. 

Polysorbate 80

The function of Polysorbate 80 is an emulsifier which stops oil form separating out from water. Polysorbate 80 is commonly used in food and drink. Polysorbate 80 is used in both medicines and several vaccines, and has been studied with recognised safety thresholds. It is present in some intravenous vitamin infusions at a much higher dose (32.5 mg/kg/day in neonates) than vaccines (upto 4.8mg/kg given into muscles).
To damage the BBB, doses of 90mg/kg are needed which are a staggering amount (1700% increase and injected into bloodstream) that Dr. Palevsky chose not to mention and is way beyond any normal vaccine.

Getting medicines across the BBB has been a difficult task in research and polysorbate 80 has proven itself as effective compound and transporter in medicine delivery, being well studied. It can form nanoparticles but not with aluminum or with aluminium salts that are used in vaccines.
Aluminum can enter the BBB via various mechanisms however as aluminum is a charged 3+ positive ion it cannot diffuse through the BBB alone, it requires the use of carriers to transport on. Polysorbate 80 doesn’t have the correct structure to bind aluminum (it would need two ketones at close proximity) and also secondly the aluminium would need to repel the water in serum (hydrophobic properties) which can’t happen alone due to its strong charge. In other words it’s fantasy that contradicts basic chemical concepts and thus absurdness that a non-scientific audience would be unprepared for.

Placebo controlled trials & Long-term safety studies

The negation of placebo controlled vaccines trials is untrue and this is discussed at Vaxopedia by Dr. Vincent Iannelli. The negation of long term vaccine studies is yet further misinformation. Again see Vaxopedia for examples with one study being as long as 20 years.  Vaccines undergo preclinical testing to the level of phase 3 trials, just like medicines (again more convenient misinformation asserted by Dr. Palevsky) thereby determing safety, risk of inducing illness, ability to induce immune response and for overall effectiveness (efficacy) before they are licensed and allowed to be clinically used.
Furthermore, given that aluminium adjuvant vaccines have been very widely use for some 70 years, that is the longest accumulative evidence we have, more than any study could offer. Real life usuage picks up even more rare side-effects than in studies, like effects that are seen in one person in every 100,000. This sort of rarity will only be picked up when using the vaccine or medicine on millions or even tens of millions of participants. Studies are not usually that big, but we do occasionally find side-effects that rare but only by real-life usuage and if they’re serious the medicine is withdrawn or limits placed on its use. Aluminium adjuvant have decades of real life usuage behind them and probably used over billions of times and could pick up rare effects as low as 1 in 10 million and probably even in 100 million.

Vaccines allegedly increasing virulence

The long-term effectiveness of vaccines differ and in particular the pertussis vaccine seems to be waning and wearing off earlier than was anticipated however this is not the same as causing increased infectivity. Even immunity that is a result of the disease itself also tends to wane in pertussis and several other infectious diseases too; immunity is not life long irrespective of illness or vaccine. Andrew Wakefield is a well-known discredited surgeon who falsified a study and subsequently claimed that the measles virus is mutating in response to the MMR vaccine thereby become more virulent. Now here we are again seeing Dr. Palevsky echoing that same concept and it’s not true as discussed by Dr. David Gorski.

Vaccinated verses unvaccinated studies

There are many discussions of studies that compare the health of vaccinated children to unvaccinated children and again it’s not in favour of what Dr. Palevsky is attempting to paint, as summarised in the table below.vaccinated vs unvaccinated 3 17967432811680197088Rather the fully vaccinated are at far lower risk of becoming unwell to the diseases that they are vaccinated against and just as healthy if not more in other aspects.
However non-vaccination can put all at risk as we mentioned earlier and likewise with vaccinations that are delayed or out of sequence of the recommended schedule are putting all at risk too. The anti-vaccine lobby often misuses such studies to discredit vaccination while failing to take into consideration delayed and out of sequence vaccination. These latter two groups are in essence a form of selection bias as the underlying reasons for their delay is because of an already emerging chronic illness. I will try to discuss this further on another occasion.

Summary

  • Aluminium is all around us in our food, drink, air, perspirants, cosmetics and in some medicines including some vaccines.
  • Aluminium in very large quantities is toxic and even more quantities are needed to become neurotoxic to our brains. This is the case with nearly all other metals and salts including table salt, that they become toxic at high levels.
  • The body regulates the blood levels of aluminium and a single vaccine only increases it by 0.8% from baseline where as toxicity would need 400% increase of the upper limit of normal, while neurotoxicity would need at least 1200% increase.
  • Aluminium from food in extremely high amounts on a chronic bases can cross the blood brain barrier, BBB, just like very high amounts of aluminium in intravenous feeding or any other source.
  • Aluminium adjuvants in the current clinical vaccines are not regarded as nanoparticles but rather microparticles. Nanoparticle adjuvant vaccinces are only being tested in the laboratories and not used clinically.
  • Polysorbate 80 can cross the BBB, and is often used for that specific reason in some medicines but it doesn’t bind to aluminium, nor form nanoparticles with aluminium. The amount of Polysorbate 80 within vaccines would need to be many folds higher (1700% increase and injected into bloodstream) to damage the BBB.
  • Vaccines are well tested with long term studies with some as long as 20 years.  More so vaccines undergo preclinical testing to the level of phase 3 trials, just like medicines before they are licensed and used clinically.
  • Real life usuage of alumium containing vaccines of the past several decades would have demonstrated and quantified more rare side effects as well as any common ones too.
  • If a handful of paediatric doctors make claims, then we need to look at the evidence behind them claims. If it’s misinformation piled on top of more misinformation, painting a fictitious picture having no basis, then it may well explain why the rest of hundreds of other paediatricians around the globe do not agree with them few. Likewise it explains why the many dozens of infectious disease physicians, epidemiologists and public health physicians don’t agree either.

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