Vaccines and Adjuvants: Aluminum
Just the facts, M’aam.
| DR. ROBERT W. MALONE NOV 28 |
Image of Bohmite, the mineral version of the common Aluminum vaccine adjuvant known as Alum. Chemically, the crystalline aluminum oxyhydroxide AIOOH. The structure consists of corrugated sheets of aluminum octahedra.
Are all vaccines similar, and what ingredients are in vaccines?
Each approved vaccine is a unique mixture of both ingredients and manufacturing processes. From a regulatory standpoint, vaccine products are a combination of ingredients, manufacturing process, process controls (including release testing), and supporting safety and efficacy/effectiveness testing. The repeated assertion that all vaccines are safe and effective is mere propaganda. Each licensed vaccine product has its own profile of risks, benefits, pharmacology, immunology, and other characteristics.
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For the sake of discussion, vaccine products can be divided into three general categories.
Live Vaccines
Classically, “live” vaccines are essentially replication-competent viruses, bacteria, or potentially other replication-competent biological material. Simple examples include the oral polio vaccine, the yellow fever vaccine, the smallpox vaccine, and the Tuberculosis vaccine (BCG). A more recent example of this category is the “Flumist” influenza virus vaccine. In all of these cases, the patient is offered a product that actually infects them in some way, but – assuming that they have a “normal” properly functioning immune system – will not cause clinical disease. If the patient is immunosuppressed in some way, all bets are off. In the case of “live” vaccines, dosage, purity, identity, and “titer” of the product are critical. To illustrate this with a simple example, if you take multiple doses of yellow fever vaccine in close succession, you will get clinical yellow fever, and it can kill you. In general, “live” vaccines are the most effective, as they most closely mimic actual infection by a pathogen. However, they do cause the cells and tissues of your body to actually manufacture foreign proteins, similar to gene therapy-based vaccines.
Dead Vaccines.
“Dead” vaccines were originally prepared by taking a “live” replication-competent agent (virus or bacteria), growing it in some sort of material that will support replication (fermentation broth, cell culture, or fertile/embryonated chicken eggs for example) and “killing” or inactivating it in some way, typically by adding a chemical that would either break up the agent into its components, or damage its genome so that it could no longer replicate. One major problem with these types of products is purity, as this category is prone to contamination coming from the material used to support replication of the pathogen. The early anthrax vaccines used by the US Military during “Desert Storm” were notoriously “dirty” or contaminated with material that had nothing to do with the parts of the killed anthrax that were intended to be included in the product. Over time, various methods have been developed to produce much purer “antigens” or immunogenic components (including the use of recombinant DNA together with fermentation and advanced purification technology), but the paradox has been that as the preparations became purer, their “immunogenicity” was reduced. Essentially, the impurities were biologically active and often increased the adaptive (and innate) immune response to the intended “antigen” from the pathogen. This relates to the topic at hand, that being the use of “adjuvants” in vaccines. A related point is that, in the case of modern “subunit” vaccines produced using recombinant DNA technology, the biologically active “antigen” is produced outside your body and then injected. This is very different from the next and newest category of vaccines and technologies.
Gene Therapy-based Vaccines
The newest (third) category involves the use of recombinant DNA and/or gene therapy technologies to cause your body to manufacture some part of a pathogen, which, when presented to your immune system by your own cells, causes your body to mount an immune response (innate and/or adaptive) to the foreign protein derived from a pathogen. In many ways, this is similar to the first category, live attenuated vaccines. In the case of live attenuated vaccines, a weakened version of the pathogen is injected (or swallowed) and it replicates in your body. In the case of gene therapy-based vaccines, either a recombinant virus (such as an adenovirus) or a non-viral gene delivery formulation (mod mRNA or DNA) is administered, and this causes your body to produce a part of the pathogen (such as the spike protein from SARS-CoV-2). Another variant of this involves engineering the vesiculovirus (VSV) to display an Ebola virus protein on its surface – this is the Merck VSV Ebola vaccine. In that case, the VSV acts both as a gene therapy vector producing a specific adaptive immune response to Ebola, and also triggers a strong innate immune response. Up for discussion in that case is which is the more important active component. The latest version of gene therapy tech used for vaccination involves self-replicating RNA vectors based on alphaviruses.
In the case of the lipid nanoparticle-delivered mod mRNA vaccines, the inclusion of small DNA fragments derived from the bacterial DNA used to make the mod mRNA is probably a form of an adjuvant, much like other adjuvants commonly used with “killed” vaccines.
Adjuvants and Vaccines
What is an adjuvant? Quite simply, a vaccine adjuvant is any substance or compound added to a vaccine to enhance the body’s immune response to the antigen (the part of the vaccine that mimics the pathogen). This broad definition underscores the “anything goes” nature of adjuvants. You can find a pretty comprehensive list of known adjuvants here. This list was compiled by vaccine experts from both DoD and NIH/NIAID who were friends of mine, back in the days when I was very involved in AIDS vaccine development. It used to be available for download on the NIH website, but has since been removed. Fortunately, I kept a copy and have now made it available for downloading. It is a bit dated, but still represents the most comprehensive summary of adjuvants that I am aware of.
Adjuvants are used by researchers and the vaccine industry to stimulate adaptive immune responses to pathogen-specific antigens. At a simplistic level, you can think of an adjuvant as something that provides a “danger signal” to the immune system, causing it to respond to a foreign molecule when it otherwise might not respond. Typical adjuvants act to increase the strength and duration of the immune response, allow lower doses of antigen to be effective (dose-sparing), broaden the immune response (e.g., against drifting viral strains), direct the type of immune response (e.g., favor antibody production or T-cell activation), and improve overall vaccine efficacy in populations with weaker responses (infants, elderly, immunocompromised).
As discussed above regarding the category of “dead” vaccines, industry experience has been that, in general, the more pure the vaccine antigen, the less active it is for eliciting a robust adaptive (B and T cell) immune response. In other words, An adjuvant is an immune-response “booster” deliberately included in some vaccines to make them work better.
General categories of adjuvants include the following:
- Aluminum salts (alum) – oldest and most widely used (in many childhood vaccines like DTaP, hepatitis B)
- Oil-in-water emulsions – e.g., MF59 (in some flu vaccines for elderly), AS03 (in pandemic flu vaccines)
- Liposome-based – e.g., AS01 (in Shingrix shingles vaccine and some malaria vaccines)
- TLR agonists – e.g., CpG 1018 (in Heplisav-B hepatitis B vaccine), MPL (in Shingrix)
- Saponin-based – e.g., QS-21 (in Shingrix and some COVID/malaria vaccines)
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Aluminum Adjuvants and Vaccines
Various forms and formulations of aluminum salts are used as vaccine adjuvants. These preparations are among the oldest and most widely used adjuvants. These are NOT the same as powdered metallic aluminum or free aluminum ions, which ARE highly toxic to humans.
- Almost every inactivated or subunit vaccine given to infants and young children contains aluminum (except pneumococcal conjugates and Hib PedvaxHIB).
- Many novel or experimental adjuvants employ aluminum salts together with other agents (liposomes etc.)
- Most live vaccines and modern conjugate/mod mRNA vaccines do not contain aluminum.
Clinical Syndromes associated with aluminum powder, aluminum ion or injected aluminum exposure toxicity include
- Dialysis encephalopathy (dialytic dementia)
- Caused by high aluminum in dialysis fluid pre-1980s
- Symptoms: speech disturbance, seizures, myoclonus, psychosis
- Now extremely rare due to water treatment standards
- Parenteral Neonatal (PN) Aluminum Toxicity
- Preterm infants exposed to 4–5 μg/kg/day IV aluminum via parenteral nutrition show neurodevelopmental and bone toxicity.
- These findings led to FDA aluminum limits for parenteral nutrition solutions.
- Vaccine-day aluminum doses, although differing in chemical structure from free aluminum ions, can be orders of magnitude higher per kg than PN limits.
- Aluminum-induced bone disease (osteomalacia)
- Seen in long-term parenteral nutrition or dialysis patients
- Fracturing bone pain, hypercalcemia, resistance to vitamin D
- Pulmonary fibrosis / aluminosis
- From chronic intense inhalation of aluminum powder
- Rare occupational disease
- Macrophagic myofasciitis (MMF)
- Persistent aluminum-containing granulomas at intramuscular injection sites (mostly deltoid)
- Symptoms in many MMF patients: chronic myalgias, fatigue, and cognitive difficulties.
- Detected in some patients with myalgia, fatigue, and cognitive issues
- Causal link to systemic symptoms is not universally accepted
- Muscle biopsies show aluminum-loaded macrophages (MMF lesions) at prior vaccine sites years later. This demonstrates long-term persistence of aluminum adjuvants in human tissue.
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