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Originally on Malone News on Substack
By Dr. Robert Malone
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.
For the sake of discussion, vaccine products can be divided into three general categories.
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 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.
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.
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:
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.
Note that none of these are elemental or ionic free aluminum forms, but rather comprise various aggregate or semi-crystalline forms of aluminum. Therefore, information involving pharmacodynamics, pharmacokinetics, pharmacodistribution, general toxicology, and pathology developed using exposure to elemental or ionic forms of aluminum are unlikely to be fully predictive for these alternative forms and formulations of aluminum.
SAFETY/TOXICITY: May cause mild local reactions at the site of injection (erythema and/or mild transient swellings).
• Yamanaka, M. et al., 1992, Pathological studies on local tissue reactions in guinea pigs and rats caused by four different adjuvants, J. Vet. Med. Sci. 54:685-692.
• Gupta. R. K., et al., 1993, Adjuvants- A balance between toxicity and adjuvanticity, Vaccine 11:293-306.
SAFETY/TOXICITY: May cause mild local reactions at the site of injection (erythemas and/or mild transient swellings).
• Gaarot, P. 0., 1986, Metabolism and possible health effects of aluminurn. Environ. Health Perspect. 65:363-441,
• Gupta, R. K-eral., 1993, Adjuvants-A balance between toxicity and adjuvanticity, Vaccine 11:293306.
SAFETY/TOXICITY: Aluminum compounds (aluminum hydroxide, aluminum phosphate, alum) are currently the only vaccine adjuvants used in US-licensed vaccines. They can induce granulomas at the inoculation site. Supplied pyrogen free.
• Ganrot, P. 0., 1986, Metabolism and possible health effects of aluminum. Environ. Health Persp., 65:363441.
The following is a comprehensive list of commonly used vaccines that contain aluminum salt adjuvants (aluminum hydroxide, aluminum phosphate, or potassium aluminum sulfate/alum) as of 2025.
Routine Childhood/Adolescent Vaccines (Containing Aluminum). Almost all non-live vaccines for infants/children use aluminum adjuvants.
Adult and Travel Vaccines (Containing Aluminum)
Federal Aluminum Regulatory Limits: The U.S. Code of Federal Regulations (21 CFR 610.15(a)) limits aluminum in vaccines to ≤0.85 mg per dose, regardless of age group. This limit is derived from pharmacokinetic (PK) and safety studies showing no significant systemic exposure or toxicity at this level in animal models (e.g., rabbits). Doses up to 0.85 mg Al IM in rabbits resulted in transient blood results in Al increases (<15 µg/L) that resolved quickly, with no acute or chronic adverse effects observed. This currently serves as the FDA-accepted NOAEL (no adverse event level) benchmark for human vaccine use.
The Agency for Toxic Substances and Disease Registry (ATSDR) is a federal public health agency within the U.S. Department of Health and Human Services (HHS). ASTDR has assessed and determined a “minimum risk level” (MRL, somewhat akin to NOAEL determination typically used by FDA) for orally ingested aluminum (very low absorption), which cannot be considered equivalent to injected forms. ATSDR: oral minimal risk level ≈ 1 mg (1,000 μg) Al/kg/day based on animal data. This assumes only ~0.1% oral absorption. Converted to an injected-equivalent threshold, this approximates 1 μg/kg/day.
Although the FDA imposes individual dose limits on vaccine-associated aluminum during licensure, it does not provide oversight or guidance on concurrent or proximal administration of multiple aluminum-containing vaccines. This issue is illustrated in the following graphic:
In the only published/peer-reviewed study of aluminum ion blood levels observed in infants after aluminum-adjuvant containing vaccine administration (Movsas et al. (2013), serum aluminum levels measured before and 24 hours after vaccination showed no significant mean increase. This exploratory study is associated with significant limitations, including very small sample size (n= 15), only 24-hour follow-up, and no organ or long-term distribution data.
Experimental and clinical data suggest IM aluminum can persist at the injection site, then migrate via immune cells to liver, spleen, and brain. Exley and colleagues have demonstrated that aluminum is detectable in most human brains, reflecting cumulative environmental exposure. Very high aluminum levels have been reported in brains from individuals with autism, AD, MS, and other conditions. In autism studies, aluminum in the brain is often localized within microglia and other inflammatory cells.
Curr Med Chem 2011;18(17):2630-7. L Tomljenovic, C A Shaw
Neural Dynamics Research Group, Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, BC, V5Z 1L8, Canada.
Abstract
Aluminum is an experimentally demonstrated neurotoxin and the most commonly used vaccine adjuvant. Despite almost 90 years of widespread use of aluminum adjuvants, medical science’s understanding about their mechanisms of action is still remarkably poor. There is also a concerning scarcity of data on toxicology and pharmacokinetics of these compounds. In spite of this, the notion that aluminum in vaccines is safe appears to be widely accepted. Experimental research, however, clearly shows that aluminum adjuvants have a potential to induce serious immunological disorders in humans. In particular, aluminum in adjuvant form carries a risk for autoimmunity, long-term brain inflammation and associated neurological complications and may thus have profound and widespread adverse health consequences. In our opinion, the possibility that vaccine benefits may have been overrated and the risk of potential adverse effects underestimated, has not been rigorously evaluated in the medical and scientific community.
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