Here is a link to a technical report regarding the presence in Pfizer's BNT162b2 "vaccine" of toxic synthetic compounds used as vehicle for the delivery of genetic material.
https://drive.google.com/file/d/13p4wCO ... sp=sharing
It is signed by Giovanna Gomes Lara. I don´t know much about her, but her resumé says she has an MSc in biomedical engineering and a PhD focusing on mesoporous silica nanoparticles functionalized with gap-junction blockers and antioxidants against the effects of radiotherapy.
I Google-translated the main text:
In addition to the gene sequence that codes for the 'spike' of the said SARS-Cov2, some substances that make up the lipid nanoparticle (fat) in the so-called vaccine are of concern. These components are ALC 0315 and ALC 0159. These substances having never been tested in humans before the mass inoculation campaign promoted by the MoH. There were at least 14 changes in the package insert. The last modification consists of the inclusion of a cardioplegic and correction substance called tromethamine for the product to be injected into children between 5 and 11 years old. The term cardioplegic solution means that its use is intended to stabilize cardiac function in cardiogenic shock (inability of the heart to pump blood). The addition of such a substance to vials intended for children from 5 to 11 years of age suggests an adverse effect already expected and not declared in the package insert of the gene therapy product. In this report we analyze each of the compounds mentioned above with regard to studies carried out in vitro and in vivo as well as the situation of authorization of their use in humans.
This technical report was requested for an ongoing lawsuit referring to the inclusion of substances in gene therapy products not approved for human use or suspended due to the need for safety analysis.
1) ALC 0315 and
2) ALC 0159
The two compounds known as ALC 0315 and ALC 0159 are synthetic, artificial long-chain carbon compounds that in aqueous solution form micelles (spheres) with their polar part directed towards the outside of the micelle and the nonpolar (uncharged) part directed towards the inner side. These compounds have been used as vehicles for the delivery of artificial/exogenous genetic material into cells in laboratory culture in order to modify the expression of a gene and, consequently, cellular functioning.
In the manufacturer's information document on these compounds, two statements are made: 1) that these compounds are not authorized for either veterinary or human use, being for research only and not for the purpose of diagnosis or therapy; 2) both compounds are present in the "vaccine" (quotes by the author of this report) BNT162b2 against SARS-Cov2. In an additional item of the document, ALC 0315 is listed as a carcinogen while for ALC 0159 such effect has not yet been evaluated. The triggering of anaphylactic shock in recipients of BNT162b2 is already documented and reports continue to be added to the VAERS (Vaccine Adverse Events Reporting System), an American system for reporting adverse effects from vaccines. Another article admits that there is no FDA-approved human use of the two substances. Lipid nanoparticles trigger anaphylactic shock by activating the complement system, a sequence of molecules that open pores in cells, killing them.
The only pre-clinical test biodistribution study done was provided by the Japanese regulatory agency presented by Pfizer. This document reports the slow metabolism of ALC 0315 and ALC 0159 with accumulation of these in the liver, adrenals, bone marrow (where blood cells are produced), kidneys, spleen, ovaries and prostate of rats and mice.
Tromethamine, according to its pharmacological description, is a compound used in the control of metabolic acidosis (low blood pH) as an alternative to sodium bicarbonate solution administered intravenously. Tromethamine is currently suspended according to information from drugs.com, one of the largest drug platforms for consultation in both the US and Europe, as well as in the FDA's orange book. The substance in question is produced by a single company, HOSPIRA, acquired by Pfizer in 2015. Its manufacture ceased in 2016. In addition to this fact, regarding the available literature on the interaction of tromethamine with proteins, there is a publication that reports the inhibition of APP (protein amyloid beta) in vitro without the presence of cells in culture. APP is responsible for controlling the growth of neurons and the formation of nerve synapses. The scarcity of in vitro and in vivo studies raises serious questions about its safety for humans. The International Agency for Research on Cancer classifies this substance in its group 3. This category contains substances on which carcinogenicity studies (ability to cause cancer) in humans are inadequate and animal experiments are also inadequate and the results are suggestive of carcinogenic action, but "not conclusive".
Pfizer's latest TG product package insert, available on the ANVISA website, recently included tromethamine as an excipient intended for inoculations in children aged 5 to 11 years. Tromethamine is a compound that has already been used in cardioplegic buffer solution whose function would be to protect the heart from damage caused by ischemia (decreased blood flow in a given human tissue) during cardiac surgeries. However, its use in these situations was also replaced by other substances because tromethamine caused damage to the cardiac tissue that it was supposed to protect. Even before the suspension of tromethamine, it was not indicated for intramuscular administration, however, via TG administration. In the same package insert the concentration of tromethamine in the final product is not informed. The limited literature on administration procedures, especially in infants and older children, recommends the use of catheters for the administration and monitoring of CO2 and O2 (carbon dioxide and oxygen, respectively) pressure due to sudden changes in gas tension as well as to avoid local necrosis. The application of tromethamine even intravenously by administration vehicles (eg needles) of very small gauge lead to local tissue necrosis. Publications from the 1960s describe extensive liver damage from necrosis.
Necrosis is a type of cell death that leads to a state of intense inflammation with the release of inflammatory substances (e.g. Nuclear Factor-B and Interleukin-6) by necrotic cells and production of pro-inflammatory cytokines by neighboring tissues, which may affect other organs. Animal tests at various doses (8-16mM tromethamine/kg) showed high toxicity in the liver, kidney, spleen and heart of mice and rabbits. Neither did the addition of sodium chloride (NaCl, salt) decrease the toxicity of tromethamine. After 24 hours of administration of the compound, it was still detected in the body of the animals tested, which justifies studies of its excretion. According to current data, tromethamine is not metabolized by the human body. The compost must be kept between 20 and 25 degrees, and freezing is prohibited. However, in the current Pfizer package insert it says that the bottle with the finished product should be stored between -90 and -60 degrees. No studies on stability at these temperatures were located.
(actual page count, not page numbers)
Page 7: contract between Pfizer and the Brazilian government (in Portuguese)
Pages 8-56: Wyeth Comirnaty fact sheet (in Portuguese)
Pages 57-61: History of changes in the fact sheet/insert (in Portuguese)
Pages 62-73: Echelon Biosciences Inc. fact sheet on ALC-0315 (in English)
Pages 74-81: Echelon Biosciences Inc. fact sheet on ALC-0159 (in English)
Pages 82-83: Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (in English)
Pages 84-86: Tromethamine (drugs.com) (in English)
Page 87: Tromethamine Discontinuation (in English)
Pages 88-96: Acquisition of HOSPIRA by Pfizer (in English)
Pages 97-112: Confidential Pfizer study on pharmacokinetics (in English)
Page 114: Biologist's ID and driver's license of Giovanna Gomes Lara
Pages 115-117: Resumé