Aluminum

Common Questions About Vaccine Adjuvants

What is an adjuvant?

Adjuvants are substances added to vaccines to help “improve” the body’s immune response to the vaccine.

The word adjuvant comes from Latin word adjuvare which means “to help”–but this is technically a euphemism, because the way adjuvants “help” is by being cytotoxic, and damaging to cells and tissue to alert the immune system.

Vaccines are coaxing your body into thinking it’s being infected by a natural germ, and aluminum is a crucial part of the trick. Aluminum is a metal that is lighting a fire for your immune system to put out, by sending in the various immune cells required to initiate the desired immune response that would result in antibody production. However, this aluminum nanoparticle (AI3+) is indestructible and outlives the cells that come to destroy it, and not eliminated or excreted by the body (see below), so it can become a chronic source of inflammation and immune reaction in the body.

Further scientific reading:

“One hypothesis is that stress signals released by aluminum-exposed necrotic cells play a role in modulating an immune response that contributes to the adjuvant’s effectiveness.” (Source)

“…damage-associated molecular patterns-type adjuvants that act by killing cells so that their released products trigger inflammation.” (Source)

“Intramuscular injection of alum-containing vaccine was associated with the appearance of aluminum deposits in distant organs, such as spleen and brain where they were still detected one year after injection.” (Source

What are some common vaccine adjuvants?

The most common vaccine adjuvants for pediatric vaccines are aluminum containing adjuvants. Aluminum was named “Allergen of the Year” for 2022 by the American Contact Dermatitis Society (ACDS). Aluminum salts are major causes of allergic reactions.

Other vaccines such as flu vaccines, or travel vaccines, and vaccines for the elderly population may have other adjuvants.

  • Aluminum salts: such as aluminum hydroxide, aluminum phosphate, and potassium aluminum sulfate, as well as amorphous aluminumhydroxyphosphate sulfate (AAHS), which is used in human papillomavirus (HPV).
  • MF59: an oil-in-water emulsion, which contains squalene, used in the influenza vaccine for older adults
  • AS03: a squalene-based oil-in-water emulsion, used in some influenza vaccines and the H1N1 pandemic vaccine
  • QS-21: a saponin-based adjuvant, used in the malaria vaccine and some cancer vaccines
  • CpG oligonucleotides: synthetic DNA molecules, used in some cancer vaccines and experimental vaccines for infectious diseases.

Which pediatric vaccines contain adjuvants?

Vaccines that do not contain “live” or inactivated viruses contain adjuvants:

  • DTaP (Diphtheria, Tetanus, acellular Pertussis) – contains aluminum hydroxide or aluminum phosphate as an adjuvant
  • Hib (Haemophilus influenzae type b) – one brand of hib ((PedvaxHIB) contains amorphous aluminumhydroxyphosphate sulfate (AAHS)
  • HepA (Hepatitis A) – contains aluminum hydroxide or amorphous aluminumhydroxyphosphate sulfate (AAHS)
  • HepB (Hepatitis B) – contains aluminum hydroxide or amorphous aluminumhydroxyphosphate sulfate (AAHS)
  • HPV (Human papillomavirus) – contains amorphous aluminumhydroxyphosphate sulfate (AAHS)
  • Influenza (flu) – contains aluminum, MF59, or AS03 as adjuvants depending on the formulation
  • MMR (Measles, Mumps, Rubella) – contains 3 live attenuated viruses so does not contain an adjuvant
  • Meningococcal – contains aluminum hydroxide or aluminum phosphate or MF59 as adjuvants depending on the formulation
  • PCV13 (Pneumococcal conjugate vaccine) – contains aluminum phosphate as an adjuvant
  • Polio (IPV) – contains a whole inactivated virus so does not contain an adjuvant
  • Rotavirus – oral – contains live attenuated virus, so does not contain an adjuvant
  • Tdap (Tetanus, Diphtheria, acellular Pertussis) – contains aluminum hydroxide as an adjuvant
  • Varicella (Chickenpox) – contains a live attenuated virus so does not contain an adjuvant

Live attenuated vaccines do not contain adjuvants, but do contain live viruses that in some cases may cause infection, rash, and even spread (transmit) to others. This is why the vaccine inserts for these vaccines include disclaimers regarding specific risks of vaccine virus transmission.

How much aluminum is in each vaccine?

  • HepB (Hepatitis B) = 250 to 500 mcg (Engerix or Recombivax)
  • Rotavirus = 0 mcg (oral vaccine)
  • DTaP (diptheria, tetanus and acellular pertussis) = ranges from 170 mcg (Tripedia), 330 mcg (Daptacel), 625 (Infanrix)
  • HiB (Haemophilus influenzae B.  = 225 mcg (PedvaxHIB), or 0 mcg (ActHIB)
  • PCV (Pneumococcal) = 125 mcg (Prevnar-13)
  • IPV (inactivated polio) = 0 mcg
  • MMR (Measles, Mumps, Rubella) = 0 mcg
  • Varicella (Chickenpox) = 0 mcg
  • Hep A (Hepatitis A) = 250 mcg (HAVRIX and VAQTA)
  • COMVAX (Hib + HepB) = 225 mcg
  • Pediarix (DTaP + HepB + IPV) = 850 mcg
  • Pentacel (DTaP + IPV + Hib) = 1.5 mg (330 mcg)
  • Kinrix (DTaP + IPV) = 600 mcg
  • Pedvaxhib (Hib + HepB) = 225 mcg
  • Quadracel (DTaP + IPV) = 1.5 mg (0.33 mg aluminum)
  • Twinrix (HepB + HepA) = 450 mcg
  • Vaxelis (DTaP + IPV + HepB) = 319 mcg aluminum from aluminum salts

 

Infants who follow the CDC recommended vaccine schedule received multiple injections of aluminum containing vaccines at each well baby visit. By 18 months of age, an infant will have been injected with 4,925 mcg of aluminum, or 4.925 milligrams. Most of this aluminum is not eliminated by the body, since there are extremely different absorption rates for oral verses injected aluminum.

Aluminum at each well baby visit:

At Birth 250 mcg
2 Months 1225 mcg
4 Months 975 mcg
6 Months 1000 mcg
12 Months 600 mcg
15 Months 625 mcg
18 Months 250 mcg

Total: 4,925 mcg of aluminum

 

What is the “safe limit” of aluminum according to the FDA?

Due to the risks of aluminum toxicity, the FDA recommends that the total allowable aluminum exposure from parenteral nutrition should not exceed 5 mcg/kg/day. This is much less than what is given to an infant in the form of a vaccine.

Because the vaccine composition is injected into a muscle, the injected aluminum is not eliminated by the body.

Are vaccine adjuvants safe?

While some vaccine adjuvants like aluminum hydroxide have been used since the 1930’s in early versions of vaccines, there is no research that actually proves its safety with meaningful evidence, such as long-term observational studies deliberately trying to prove or disprove the safety of adjuvants.

Aluminum salts were granted “generally recognized as safe” status (GRAS) in 1975, which means it was able to skirt around pre-market review and approval by the FDA.

Concern regarding aluminum adjuvants:

1977: A simplified technique for producing aluminum hydroxide-induced chronic focal seizures in monkeys

1980: Vaccine adjuvants

“To date, the question of adjuvant safety has not been resolved and represents the major obstacle to the orderly development of adjuvanted vaccines. The fear of inducing cancer and other immediate or long-term perturbations of the immune system must be patently and rationally overcome by basic and applied experimentation and by the development of appropriate guidelines for studies in humans.”

2002: Neurological adverse events associated with vaccination

2017: Severe manifestations of autoimmune syndrome induced by adjuvants (Shoenfeld’s syndrome)

2017: Critical analysis of reference studies on the toxicokinetics of aluminum-based adjuvants

2018: Aluminium Adjuvants – a Nanomaterial used as Adjuvants in Human Vaccines for Decades

“Conclusions: A persistent intracellular accumulation of aluminium adjuvants will be a solid depository of sparingly sparingly soluble aluminium salts maintaining a constant concentration of Al3+ ions in the cytoplasm and this will affect multiple biochemical processes. The cell will be under constant stress and DAMP signalling will occur and we would like to suggest the maintenance of a constant concentration Al3+ ions in the cytoplasm as a general underlying feature of the immune stimulation properties of aluminium adjuvants.”

2018: Pediatric Wells syndrome (eosinophilic cellulitis) after vaccination: A case report and review of the literature

2018: Aluminum in neurological disease – a 36 year multicenter study

“Amongst these 18 common neurological conditions and controls we report a statistically significant trend for aluminum to be increased only in AD, DS and DDS compared to age- and gender-matched brains from the same anatomical region.  (Alzheimer’s disease (AD), Dialysis dementia syndrome (DDS), Downs syndrome (DS; Trisomy 21))”

2018: Altered vaccine-induced immunity in children with Dravet syndrome

“Vaccination is the trigger of the first seizure in about 50% of cases.”

2021: Reviewing the association between aluminum adjuvants in the vaccines and autism spectrum disorder

2023: Association Between Aluminum Exposure From Vaccines Before Age 24 Months and Persistent Asthma at Age 24 to 59 Months

“In a large observational study, a positive association was found between vaccine-related aluminum exposure and persistent asthma.” 

2023: Aluminum hydroxide exposure induces neurodevelopmental impairment in hESC-derived cerebral organoids

“We found that early Al(OH)3 exposure in organoids caused a reduction in the size, deficits in basal neural progenitor cell (NPC) proliferation, and premature neuron differentiation in a time and dose-dependent manner. Transcriptomes analysis revealed a markedly altered Hippo-YAP1 signaling pathway in Al(OH)3 exposed cerebral organoid, uncovering a novel mechanism for Al(OH)3-induced detrimental to neurogenesis during human cortical development.”

Are Aluminum Adjuvants eliminated rapidly by the body?

A single experimental study was carried out using isotopic 26Al (Flarend et al., Vaccine, 1997). This study used aluminum salts resembling those used in vaccines but ignored adjuvant uptake by cells that was not fully documented at the time. It was conducted over a short period of time (28days) and used only two rabbits per adjuvant. At the endpoint, Al elimination in the urine accounted for 6% for Al hydroxide and 22% for Al phosphate, both results being incompatible with rapid elimination of vaccine-derived Al in urine. (Source)

Can vaccine adjuvants cause autism?

In order to answer this question, we would need to study a large group of children exposed to adjuvanted vaccines, to a group of children unexposed, or not exposed to adjuvanted vaccines, and that has not been done. We haven’t even done this with vaccines in general.

The research into vaccines and autism looked definitely at one vaccine: the mmr vaccine, and one ingredient which wasn’t used as an adjuvant, but rather a preservative, thimerosal.

While we are very thankful researchers studied this vaccine and that ingredient, in no way did they exhaustively study every vaccine, or the process of vaccination, and the outcome of autism.

Classic example of would need to be done is a case control study that includes a completely unexposed group:

Are vaccine adjuvants necessary?

Adjuvants are added to non-live vaccines because without a virus that has some infective ability, the ingredients in the vaccine may not be as noticeable to the immune system. In nature, toxins are noticed by the immune system. Think of a snake venom, or a spider bite. Usually stuff that gets pricked inside the skin has some kind of nervous system toxin in it, and has a function, such as to paralyze its victim while it spins a web around you. The vaccine, while inspired by the bee sting, still needs something in it to irritate and damage, thus to signal the immune system. Overall, it’s a trick, or a trojan horse situation.

And when tricking something like the immune system, stuff can go wrong, ie. auto immunity, allergy, asthma, etc. In many cases, these “changes to the immune system” which result in allergy or auto immunity (which is where you make antibodies to self proteins) become chronic and lifelong.

See Infectious Diseases.

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