They say the driving force behind this investigation (and similar earlier ones) is because so many vaccine adverse reactions go not only unreported, but unexplained. "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." To explore this, they studied 44 types of vaccines coming from 2 countries (Italy and France).
What did they find? The "presence of micro-, submicro- and nanosized, inorganic, foreign bodies (ranging from 100nm to about ten microns) was identified in all cases, whose presence was not declared in the leaflets delivered in the package of the product". They found single particles, clusters, and aggregates containing a wide variety of metals, organic material, and other debris. In the paper there are extensive graphs and charts detailing precisely which contaminants were found in which vaccines, some of which include lead, tungsten, strontium, hafnium, nickel, iron, zirconium, bismuth, cerium, stainless steel and copper.
"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 [17]. 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 protein corona effect (due to a nano-bio-interaction [18]) can produce organic/inorganic composite particles capable of stimulating the immune system in an undesirable way [19-22]. It is impossible not to add that particles the size often observed in vaccines can enter cell nuclei and interact with the DNA [23]."
"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 [30,31]."
You can read more about the findings here.
"Dr. Gatti explains that the discovery of vaccine impurities shocked the researchers. "We had never questioned the purity of vaccines before. In fact, for us the problem did not even exist. All injectable solutions had to be perfectly pure and that was an act of faith on which it seemed impossible to have doubts. For that reason, we repeated our analyses several times to be certain. In the end, we accepted the evidence."
More Evidence of Contamination
Probably the most well-known occurrence of contamination in vaccines is the contamination of nearly all doses of polio vaccine given before 1961 with the monkey virus Simian Virus 40 (aka SV40). This is a long and complicated story that is covered well in this article from The Atlantic. "A simian virus known as SV40 has been associated with a number of rare human cancers. This same virus contaminated the polio vaccine administered to 98 million Americans from 1955 to 1963. Federal health officials see little reason for concern. A growing cadre of medical researchers disagree"
Doses made after 1961 were supposed to have been checked to make sure they did not contain this virus, but existing contaminated doses were not recalled and were in use through 1963. The contamination came from the monkey kidneys that the polio virus was grown on for use in the vaccine. "Worried about creating a panic, they kept the discovery of SV40 under wraps and never recalled existing stocks. For two more years millions of additional people were needlessly exposed -- bringing the total to 98 million Americans from 1955 to 1963. But after a flurry of quick studies, health officials decided that the virus, thankfully, did not cause cancer in human beings."
"After that the story of SV40 ceased to be anything more than a medical curiosity. Even though the virus became a widely used cancer-research tool, because it caused a variety of tumors so easily in laboratory animals, for the better part of four decades there was virtually no research on what SV40 might do to people."
"Others at the National Institutes of Health -- including some of the scientists who had been around at the time of the contamination scare -- were less receptive to the novel theory. They told Carbone that the last thing anyone wanted to hear was that the exalted polio vaccine was linked to cancer. Too much was at stake. Implicating a vaccine contaminant in cancer -- even if the contamination occurred some forty years ago -- might easily shake public confidence in vaccines in general."
However, evidence of a connection between the virus and various cancers has continued to accumulate. "The possibility of a link between SV40 and brain tumors is particularly intriguing. Like mesothelioma, brain tumors have become dramatically more common in recent years. Brain tumors will be diagnosed in about 3,000 children in the United States alone this year. In 1995 Janet Butel, the chairman of the department of molecular virology and microbiology at the Baylor College of Medicine, in Texas, and her chief collaborator, John Lednicky, also a Baylor virologist, reported that they had found SV40 in a number of children's brain tumors. Butel and Lednicky reported that DNA sequencing revealed that the virus was not a hybrid but rather authentic SV40 -- the same as the SV40 found in monkeys. In the fall of 1996 an Italian research team, led by Mauro Tognon, of the University of Ferrara, announced that it had found SV40 DNA in a large percentage of brain and neurological tumors, including glioblastomas, astrocytomas, ependymomas, and papillomas of the choroid plexus. The researchers suggested that SV40 may be a "viral cofactor" involved in the sharp rise in human brain tumors. Late last year an extensive study undertaken in China reinforced those results. The study examined sixty-five brain tumors, finding SV40 in each of the eight ependymomas and two choroid-plexus papillomas, common brain tumors among children. It also found the virus in 33 to 90 percent of five other kinds of brain tumor examined. The authors, writing in the November, 1999, issue of Cancer, noted that the virus was actively expressing proteins."
Anticancer Res. 1999 May-Jun;19(3B):2173-80.
" Investigations have consistently demonstrated the oncogenic behavior of SV40 in animal models. Early epidemiologic studies were inadequate in demonstrating an increase in cancer incidence associated with contaminated vaccine. Recently, investigators have provided persuasive evidence that SV40 is present in human ependymomas, choroid plexus tumors, bone tumors, and mesotheliomas, however, the etiologic role of the virus in tumorigenesis has not been established."
Investigating Viruses in Cells Used to Make Vaccines; and Evaluating the Potential Threat Posed by Transmission of Viruses to Humans
(FDA website)
"Virus-based vaccines are made in living cells (cell substrates). Some manufacturers are investigating the use of new cell lines to make vaccines... In some cases the cell lines that are used might be tumorigenic, that is, they form tumors when injected into rodents. Some of these tumor-forming cell lines may contain cancer-causing viruses that are not actively reproducing. Such viruses are hard to detect using standard methods. These latent, or "quiet," viruses pose a potential threat, since they might become active under vaccine manufacturing conditions. Therefore, to ensure the safety of vaccines, our laboratory is investigating ways to activate latent viruses in cell lines and to detect the activated viruses, as well as other unknown viruses, using new technologies. We will then adapt our findings to detect viruses in the same types of cell substrates that are used to produce vaccines." In other words, they currently cannot detect these viruses!
Screening of Viral Pathogens from Pediatric Ileal Tissue Samples After Vaccination
"In 2010, researchers reported that the two US-licensed rotavirus vaccines contained DNA or DNA fragments from porcine circovirus (PCV). Although PCV, a common virus among pigs, is not thought to cause illness in humans, these findings raised several safety concerns."
Investigations of porcine circovirus type 1 (PCV1) in vaccine-related and other cell lines
Vaccine. 2011 Oct 26;29(46):8429-37
"Porcine circovirus type 1 (PCV1) is highly prevalent in swine and was recently reported in some rotavirus vaccines. Since animal-derived raw materials, such as cells, trypsin, and serum, can be a major source of introducing virus contamination in biological products, we have investigated PCV1 in several cell lines... MDBK cells, which are used for some animal vaccines, contained PCV1 sequences, although no virus was isolated. Although the results showed that PCV infection may not have occurred under previous culture conditions, the recent cases of vaccine contamination emphasizes the need for continued efforts to reduce the likelihood of introducing viruses from animal-derived materials used in product manufacture."
Evidence of pestivirus RNA in human virus vaccines
J Clin Microbiol. Jun 1994; 32(6): 1604–1605
(FDA website)
"Virus-based vaccines are made in living cells (cell substrates). Some manufacturers are investigating the use of new cell lines to make vaccines... In some cases the cell lines that are used might be tumorigenic, that is, they form tumors when injected into rodents. Some of these tumor-forming cell lines may contain cancer-causing viruses that are not actively reproducing. Such viruses are hard to detect using standard methods. These latent, or "quiet," viruses pose a potential threat, since they might become active under vaccine manufacturing conditions. Therefore, to ensure the safety of vaccines, our laboratory is investigating ways to activate latent viruses in cell lines and to detect the activated viruses, as well as other unknown viruses, using new technologies. We will then adapt our findings to detect viruses in the same types of cell substrates that are used to produce vaccines." In other words, they currently cannot detect these viruses!
Screening of Viral Pathogens from Pediatric Ileal Tissue Samples After Vaccination
"In 2010, researchers reported that the two US-licensed rotavirus vaccines contained DNA or DNA fragments from porcine circovirus (PCV). Although PCV, a common virus among pigs, is not thought to cause illness in humans, these findings raised several safety concerns."
Investigations of porcine circovirus type 1 (PCV1) in vaccine-related and other cell lines
Vaccine. 2011 Oct 26;29(46):8429-37
"Porcine circovirus type 1 (PCV1) is highly prevalent in swine and was recently reported in some rotavirus vaccines. Since animal-derived raw materials, such as cells, trypsin, and serum, can be a major source of introducing virus contamination in biological products, we have investigated PCV1 in several cell lines... MDBK cells, which are used for some animal vaccines, contained PCV1 sequences, although no virus was isolated. Although the results showed that PCV infection may not have occurred under previous culture conditions, the recent cases of vaccine contamination emphasizes the need for continued efforts to reduce the likelihood of introducing viruses from animal-derived materials used in product manufacture."
Evidence of pestivirus RNA in human virus vaccines
J Clin Microbiol. Jun 1994; 32(6): 1604–1605
"We examined live virus vaccines against measles, mumps, and rubella for the presence of pestivirus RNA or of pestiviruses by reverse transcription PCR. Pestivirus RNA was detected in two measles-mumps-rubella combined vaccines and in two monovalent vaccines against mumps and rubella."
Genotypes of pestivirus RNA detected in live virus vaccines for human use
J Vet Med Sci. 2001 Jul;63(7):723-33.
Genotypes of pestivirus RNA detected in live virus vaccines for human use
J Vet Med Sci. 2001 Jul;63(7):723-33.
"Five (13.1%) out of 38 tested samples were positive for pestivirus RNA... Analyses based on primary nucleotide sequence homology and on secondary structures, characteristic to genotypes, revealed that the cDNA sequences belonged to bovine viral diarrhea virus (BVDV). A cDNA sequence, detected from one measles sample, belonged to BVDV-1b genotype. Pestiviral cDNA detected from the Japanese mumps and rubella vaccine samples, belonged to the BVDV genotypes 1a and 1c, respectively. Analysis on two cDNA sequences detected from measles and rubella vaccine samples from Europe showed their appurtenance to a new genotype, BVDV-1d. These findings indicate that contamination by animal pestivirus may occur in biological products for human use."
Endotoxins in commercial vaccines
Appl Environ Microbiol. Sep 1978; 36(3): 445–449.
Endotoxins in commercial vaccines
Appl Environ Microbiol. Sep 1978; 36(3): 445–449.
"Twenty samples of commercial vaccines intended for administration to humans were assayed for the presence of bacterial endotoxins by using the Limulus amebocyte lysate test. Sixteen of the vaccines contained more than 0.1 ng of endotoxin per ml (which corresponds to 103 bacterial cell wall equivalents per ml in the undiluted vaccines). These results suggest that at some stage of preparation, the vaccines have contained varying amounts of gram-negative bacteria and may indicate the presence of other bacterial products as well. It might be useful to list the level of endotoxins, phage, and other contaminants on each vaccine lot to facilitate studies on any side effects of these contaminants. Selection of vaccine lots with the least endotoxin might reduce some of the adverse effects of vaccinations."
