New Quality-Control Investigations on Vaccines: Microand Nanocontamination

di Dott. Antonietta M. Gatti, National Council of Research of Italy, Stefano Montanari


Vaccines are being under investigation for the possible side effects they can cause. In order to supply new information, an electron-microscopy investigation method was applied to the study of vaccines, aimed at verifying the presence of solid contaminants by means of an Environmental Scanning Electron Microscope equipped with an X-ray microprobe. The results of this new investigation show the presence of micro- and nanosized particulate matter composed of inorganic elements in vaccines’ samples which is not declared among the components and whose unduly presence is, for the time being, inexplicable. A considerable part of those particulate contaminants have already been verified in other matrices and reported in literature as non biodegradable and non biocompatible. The evidence collected is suggestive of some hypotheses correlated to diseases that are mentioned and briefly discussed.


Vaccines are one of the most notable inventions meant to protect people from infectious diseases. The practice of variolation is century-old and is mentioned in Chinese and Indian documents dated around 1000 A.D. Over time, variolation has been replaced by vaccination, vaccines have been enhanced as to technology, and the vaccination practice is now standardized worldwide.

Side effects have always been reported but in the latest years it seems that they have increased in number and seriousness, particularly in children as the American Academy of pediatrics reports. For instance, the diphtheria-tetanus-pertussis (DTaP) vaccine was linked to cases of sudden infant death syndrome (SIDS); measles-mumps-rubella vaccine with autism; multiple immunizations with immune disorders; hepatitis B vaccines with multiple sclerosis, etc.

The notice of Tripedia DTaP by Sanofi Pasteur reports “Adverse events reported during post-approval use of Tripedia vaccine include idiopathic thrombocytopenic purpura, SIDS, anaphylactic reaction, cellulitis, autism, convulsion/grand mal convulsion, encephalopathia, hypotonia, neuropathy, somnolence and apnea”. The epidemiological studies carried out did not show a clear evidence of those associations, even if in 2011 the National Academy of Medicine (formerly, IOM) admitted: “Vaccines are not free from side effects, or adverse effects”.

Specific researches on components of the vaccines like adjuvants (in most instances, Aluminum salts) are already indicated as possible responsible of neurological symptoms and in some cases, in-vivo tests and epidemiological studies demonstrated a possible correlation with neurologicaldiseases. Neurological damages induced in patients under hemodialysis treated with water containing Aluminum are reported in literature.

Recently, with the worldwide-adopted vaccines against Human Papillomavirus (HPV), the debate was reawaken due to some adverse effects reported by some young subjects.

Specific studies communicated the existence of symptoms related to never-described-before syndromes developed after the vaccine was administered. For instance, Complex Regional Pain Syndrome (CRPS), Postural Orthostatic Tachycardia Syndrome (POTS), and Chronic Fatigue Syndrome (CFS). The side effects that can arise within a relatively short time can be local or systemic.

Pain at the site of injection, swelling and uncontrollable movement of the hands (though this last symptom can also be considered systemic) are described. Among the systemic effects, fever, headache, irritability, epileptic seizures, temporary speech loss, lower limbs dysaesthesia and paresis, hot flashes, sleep disorders, hypersensitivity reactions, muscle pain, recurrent syncope, constant hunger, significant gait impairment, incapacity to maintain the orthostatic posture are reported.

It is a matter of fact that every day millions of vaccine doses are administered and nothing notable happens, but it is also irrefutable that, regardless of the amount of side effects that are not recorded and the percentage of which remains in fact unknown, in a limited number cases something wrong occurs. No satisfactory explanation or, in many cases, no explanation at all has been given and it seems that those adverse effects happen on a random and stochastic basis.

Those situations induced us to verify the safety of vaccines from a point of view which was never adopted before: not a biological, but a physical approach. So, we developed a new analysis method based on the use of a Field Emission Gun Environmental Scanning Electron Microscope investigations to detect possible physical contamination in those products.


The quantity of foreign bodies detected and, in some cases, their unusual chemical compositions baffled us. The inorganic particles identified are neither biocompatible nor biodegradable, that means that they are biopersistent and can induce effects that can become evident either immediately close to injection time or after a certain time from administration. It is important to remember that particles (crystals and not molecules) are bodies foreign to the organism and they behave as such. More in particular, their toxicity is in some respects different from that of the chemical elements composing them, adding to that toxicity which, in any case, is still there, that typical of foreign bodies. For that reason, they induce an inflammatory reaction.

After being injected, those microparticles, nanoparticles and aggregates can stay around the injection site forming swellings and granulomas. But they can also be carried by the blood circulation, escaping any attempt to guess what will be their final destination. We believe that in many cases they get distributed throughout the body without causing any visible reaction, but it is also likely that, in some circumstances, they reach some organ, none excluded and including the microbiota, in a fair quantity. As happens with all foreign bodies, particularly that small, they induce an inflammatory reaction that is chronic because most of those particles cannot be degraded. Furthermore, the proteincorona effect (due to a nano-bio-interaction) can produce organic/inorganic composite particles capable of stimulating the immune system in an undesirable way. It is impossible not to add that particles the size often observed in vaccines can enter cell nuclei and interact with the DNA.

In some cases, e.g. as occurs with Iron and some Iron alloys, they can corrode and the corrosion products exert a toxicity affecting the tissues.

The detection of presence of Aluminum and NaCl salts is obvious as they are substances used by the Producers and declared as components, but other materials are not supposed to be in the vaccine or in any other injectable drug, at that, and, in any case, Aluminum has already been linked with neurological diseases.

Given the contaminations we observed in all samples of human-use vaccines, adverse effects after the injection of those vaccines are possible and credible and have the character of randomness, since they depend on where the contaminants are carried by the blood circulation. It is only obvious that similar quantities of these foreign bodies can have a more serious impact on very small organisms like those of children. Their presence in the muscles, due an extravasation from the blood, could heavily impair the muscle functionality.

We come across particles with chemical compositions, similar to those found in the vaccines we analyzed, when we study cases of environmental contamination caused by different pollution sources. In most circumstances, the combinations detected are very odd as they have no technical use, cannot be found in any material handbook and look like the result of the random formation occurring, for example, when waste is burnt. In any case, whatever their origin, they should not be present in any injectable medicament, let alone in vaccines, more in particular those meant for infants.

Other forms of so-far unknown contaminations have recently been observed and, in any case, vaccines contain components that could themselves be the cause of adverse effects. It is a well-known fact in toxicology that contaminants exert a mutual, synergic effect, and as the number of contaminants increases, the effects grow less and less predictable. The more so when some substances are unknown.

As a matter of fact, no exhaustive and reliable official data exist on the side-effects induced by vaccines. The episodic evidence reported by people allegedly damaged by vaccines is twofold: some say the damage occurred and became visible within a few hours from administration, and some maintain that it was a matter of some weeks. Though we have no indisputable evidence as to the reliability of those attestations, we can put forward a hypothesis to explain the different phenomena. In the former case, the pollutants contained in the drug have reached the brain and, depending on the anatomical site interested, have induced a reaction. If that is the case, the whole phenomenon is very rapid. In the latter circumstance, the pollutants reached the microbiota, thus interfering with the production of enzymes necessary to carry out neurological functions. That possibility takes time, as it involves the production of chemical compounds in a sufficient quantity, and an elapse of some weeks between injection and clinical evidence is reasonable. Of course, ours is no more than a hypothesis open to discussion and in need of proof, hoping that a chance of further investigation is allowed.


The analyses carried out show that in all samples checked vaccines contain non biocompatible and bio-persistent foreign bodies which are not declared by the Producers, against which the body reacts in any case. This new investigation represents a new quality control that can be adopted to assess the safety of a vaccine. Our hypothesis is that this contamination is unintentional, since it is probably due to polluted components or procedures of industrial processes (e.g. filtrations) used to produce vaccines, not investigated and not detected by the Producers. If our hypothesis is actually the case, a close inspection of the working places and the full knowledge of the whole procedure of vaccine preparation would probably allow to eliminate the problem.

A further purification of the vaccines could improve their quality and could probably decrease the number and seriousness of the adverse incidental effects.