The Sham of Vaccine Science Exposed on the UK Government Website

Please see for yourself.

The text below is taken directly from the publicly available UK government website, namely, from the “summary of the Public Assessment Report (PAR) for COVID-19 mRNA Vaccine BNT162b2.”

The first half of the quote talks about injecting poor rats and then killing them on day 17, thus proving that rats lived to the day of “scheduled death.” Methinks that the only thing it proved—assuming that the study wasn’t rigged which in this day and age is a sign of big trust—is that no rats dropped dead on the spot. Hooray.

The really outrageous stuff starts with the section titled, “Toxicokinetics.”

In the quote, I bolded the sentences—and there are lots of them—saying that no studies for various types of toxicity have been done because … wait for it … any product classified as “a vaccine” is considered safe, according to what the WHO said in 2005. Case closed.

Please see for yourself.

(And yes, it is consistent with the official Comirnaty insert that I wrote about last year.)

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3.4 Toxicology

Single dose toxicity

No single dose toxicity studies have been performed. This is acceptable and in line with relevant guidelines (WHO 2005; WHO 2014).

Repeat-dose toxicity

Study 38166 was a GLP-compliant repeat-dose study performed in rats to evaluate toxicity of the LNP and mRNA platform used in BNT162b2.

Study 20GR142 was a GLP-compliant repeat-dose study performed in rats to evaluate toxicity of COVID-19 mRNA Vaccine BNT162b2.

In Study 38166, male and female Wistar rats were given BNT162b2 as IM injection(s) into the hind limb on three occasions each a week apart (dosing days 1, 8 and 15). Different doses (10, 30, and 100 μg) were tested; the lower doses were given as a single injection of 20-70 μL, while the highest dose (100 μg) and controls were given as two injections (one in each hindlimb) of 100 μL each. The control was phosphate buffered saline/300 mM sucrose, corresponding to the storage buffer of the vaccine product. Each group had 18 male and 18 female rats, assigned as 10 to the main study, 5 for recovery groups and 3 as additional animals for cytokine analyses. The recovery period was 3 weeks after the last dose. Necropsy was performed on study day 17, ~48 hours after the last dose, and after the 3-week recovery period.

No unscheduled deaths were observed. [Wait a second, but the rats were murdered on study day 17…. so what they are saying that the rats did not die in the course of 17 days of the experiments, and beyond that… we don’t know!!! UPDATE: some rats were murdered three weeks after the last dose and not on day 17 but it does not change much about the flimsy nature of this “proof of safety.”]

Dosing was considered well tolerated and did not present any signs of systemic toxicity; there was a slight increase in body temperature in the hours after dosing and some loss in body weight over the same period but these were not of a magnitude to be considered adverse.

Local inflammatory reactions were observed at the intramuscular injection site. Injection site changes noted were of oedema [fluid retention], erythema [redmess of the skin due to injury or inflammation], and induration [hardening of a normally soft tissue or organ], more severe and more frequent after the second and/or third doses compared to the first; however, these resolved prior to subsequent dosing and were fully recovered at the end of the 3-week recovery period. [after which they were killed so we really don’t know]

Macroscopic findings at the injection sites included induration or thickening, occasionally accompanied by encrustation, which was noted for nearly all rats. This correlated microscopically with inflammation and variable fibrosis, oedema, and myofibre degeneration. Inflammation at the injection site was accompanied by elevations in circulating white blood cells and acute phase proteins (fibrinogen, alpha-2 macroglobulin, and alpha-1 acid glycoprotein).

Inflammation was occasionally evident extending into tissues adjacent to the injection site. There was enlargement of the draining (iliac) lymph nodes evident at the end of dosing. This correlated with increased cellularity of germinal centres and increased plasma cells in the draining (iliac) lymph node and is an anticipated immune response to the administered vaccine.

Enlargement of spleen and increased spleen weights correlated microscopically to increased haematopoiesis and increased haematopoiesis was also evident in the bone marrow. These findings are likely secondary to the immune/inflammatory responses to the vaccine.

At the end of the recovery period, injection sites were normal, clinical pathology findings and macroscopic observations had resolved and there was evidence of recovery of the injection site inflammation on microscopy.

Microscopic vacuolation of portal hepatocytes was present. There were no elevations in alanine aminotransferase (ALAT). There were elevations in gamma-glutamyltransferase (GGT) in all vaccinated rats, but there were no macroscopic or microscopic findings consistent with cholestasis or hepatobiliary injury to explain the increased GGT activity, which was completely resolved at the end of the 3-week recovery period.

The vacuolation may be related to hepatic distribution of the pegylated lipid in the LNP. No changes were seen in serum cytokine concentrations. Additional ADME data has been received since this authorisation and has been reviewed as part of the ongoing assessment for this product. This data is not discussed here.

There were no effects noted on ophthalmological and auditory assessments, nor on external appearance or behaviour; in particular, gait was normal meaning that the changes seen did not affect the rats’ mobility. No vaccine-related changes were seen in serum cytokine concentrations.

Testing for immunogenicity showed that COVID-19 mRNA Vaccine BNT162b2 elicited a specific IgG antibody response to SARS CoV-2 spike protein directed against the S1 fragment and the receptor binding domain. A neutralizing antibody response was also observed with the vaccine in a pseudovirus neutralization assay.

In conclusion, COVID-19 mRNA Vaccine BNT162b2 was well tolerated, and produced inflammatory changes at the injection sites and the draining lymph nodes, increased haematopoiesis in the bone marrow and spleen, and clinical pathology changes consistent with an immune response or inflammation in the injection sites. The findings in this study are typical of those expected with dosing of LNP encapsulated mRNA vaccines.

Study 20GR142 had the objective to determine toxicity in rats given COVID-19 mRNA Vaccine BNT162b2. This study was in compliance with Good Laboratory Practice. Two candidate vaccines were tested; however, results are presented here only for COVID-19 mRNA Vaccine BNT162b2.

Male and female Wistar Han rats were given BNT162b2 as an IM injection into the hind limb on three occasions, each a week apart (dosing days 1, 8 and 15). Necropsy was performed on study day 17, ~48 hours after the last dose, and after the 3-week recovery period. COVID-19 mRNA Vaccine BNT162b2 was supplied at 0.5 mg/ml, and the dose volume was 60 μL, to give 30 μg per dose. Control rats received saline. Each group contained 15 males and 15 females.

All rats given COVID-19 mRNA Vaccine BNT162b2 survived to their scheduled necropsy: there were no changes noted in clinical signs or body weight changes noted. A reduction in food intake was noted on days 4 and 11 (to 0.83x controls) and there was an increase in mean body temperature post-dose on day 1 (up to 0.54°C), day 8 (up to 0.98°C) and day 15 (up to 1.03°C) compared to controls.

At injection sites, there were instances of oedema and erythema on days 1 (maximum of slight oedema and very slight erythema), 8 (maximum of moderate oedema and very slight erythema) and 15 (maximum of moderate oedema and very slight erythema) which fully resolved and were not noted prior to dosing on days 8 and 15.

Haematological tests showed higher white blood cells (up to 2.95x controls), primarily involving neutrophils (up to 6.80x controls), monocytes (up to 3.30x controls), and large unstained cells, LUC, (up to 13.2x controls) and slightly higher eosinophils and basophils on days 4 and 17. White blood cells were higher on day 17 as compared with day 4. There were transiently lower reticulocytes on day 4 (to 0.27x controls) in both sexes and higher reticulocytes on day 17 (up to 1.31x controls) in females only. Lower red blood cell mass parameters (to 0.90x controls) were present on days 4 and 17. There were lower A:G ratios (to 0.82x) on days 4 and 17. Higher fibrinogen was noted on day 17 (up to 2.49x) compared to controls, consistent with an acute phase response. The acute phase proteins alpha-1-acid glycoprotein (up to 39x on day 17) and alpha-2 macroglobulin (up to 71x on Day 17) were elevated on days 4 and 17 with higher concentrations in males. There were no changes urinalysis parameters.

At post-mortem there were higher absolute and relative spleen weights in vaccinated rats (up to 1.42x in males and to 1.62x in females). There were no other changes in organ weights. Macroscopic findings included enlarged draining lymph nodes and pale/dark firm injection sites in a minority of vaccinated rats. The dosing is reported as tolerated without inducing any systemic toxicity and with all changes consistent with an inflammatory response and immune activation: findings are consistent with those typically associated with dosing of lipid nanoparticle-encapsulated mRNA vaccines. Since this authorisation the manufacturer has provided the final study report which has been reviewed as part of the ongoing assessment for this product and is not discussed here.

Toxicokinetics

No toxicokinetic studies have been performed with the vaccine. This is consistent with WHO guidelines on the nonclinical evaluation of vaccines (WHO 2005).

Genotoxicity

No genotoxicity studies are planned for BNT162b2, as the components of all vaccine constructs are lipids and RNA that are not expected to have genotoxic potential (WHO, 2005). [2005!!!!!!!!!]

Carcinogenicity

Carcinogenicity studies with BNT162b2 have not been conducted as the components of all vaccine constructs are lipids and RNA that are not expected to have carcinogenic or tumorigenic potential. Carcinogenicity testing is generally not considered necessary to support the development and licensure of vaccine products for infectious diseases (WHO, 2005).

Reproductive and developmental toxicity

Fertility and early embryonic development and embryofoetal development

In the general toxicity studies, macroscopic and microscopic evaluation of male and female reproductive tissues showed no evidence of toxicity. [But they merely looked at tissues, and the rats were murdered on day 17 of the experiment.]

A combined fertility and developmental study (including teratogenicity and postnatal investigations) in rats is ongoing.

Prenatal and postnatal development, including maternal function

No such studies have been done.

Studies in which the offspring (juvenile animals) are dosed and/or further evaluated

No such studies have been done.

Local tolerance

No such studies have been done. The assessments made as part of the general toxicity study should suffice and a separate study is not needed.

Other toxicity studies

No such studies have been done.

Toxicity conclusions

The absence of reproductive toxicity data is a reflection of the speed of development to first identify and select COVID-19 mRNA Vaccine BNT162b2 for clinical testing and its rapid development to meet the ongoing urgent health need. In principle, a decision on licensing a vaccine could be taken in these circumstances without data from reproductive toxicity studies animals, but there are studies ongoing and these will be provided when available. In the context of supply under Regulation 174, it is considered that sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time: however, use in women of childbearing potential could be supported provided healthcare professionals are advised to rule out known or suspected pregnancy prior to vaccination. Women who are breastfeeding should also not be vaccinated. These judgements reflect the absence of data at the present time and do not reflect a specific finding of concern. Adequate advice with regard to women of childbearing potential, pregnant women and breastfeeding women has been provided in both the Information for UK Healthcare Professionals and the Information for UK recipients.

3.5 Ecotoxicity/Environmental Risk Assessment

It is agreed that, in accordance with CHMP guidance EMEA/CHMP/SWP/4447100 entitled, “Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use” published 01 June 2006, due to their nature, vaccines and lipids are unlikely to result in a significant risk to the environment. Therefore, an environmental risk assessment is not provided in this application. This is acceptable.

This is acceptable to… WHO?


UPDATE: Link to the 2005 WHO guideline: https://www.who.int/publications/m/item/nonclinical-evaluation-of-vaccines-annex-1-trs-no-927

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