While the nature and number of reported adverse events should be enough to stop the vaccine rollout, the document that should warrant a senate inquiry into the TGA is the Nonclinical Evaluation Report (link in comments FOI-2389-6) released by the TGA in January 2021.
The following points indicate either misleading, careless or negligent behaviour from the TGA when approving the vaccine. Feel free to use this in any court action or dispute with your employer.
Note these issues only address quality assurance. The Post marketing surveillance data, vaccine injuries from the DAEN and health data from various countries showing the vaccine is not effective or safe is also compelling evidence.
1. “There are no distribution and degradation data on the S antigen-encoding mRNA. A whole-body imaging study with a surrogate, luciferase expressing mRNA indicate that the vaccine LNP formulation is expected to deliver the mRNA effectively in vivo, the mRNA and translated antigen protein are mainly localised at the injection site, distributed in liver (hepatitis anyone?) and likely draining lymph nodes, and nearly completely degraded in 9 days.”
THIS IS CRITICAL – no studies were done in animals or humans with mRNA that produced the spike protein. To not test the active ingredient and the impact that it has on the body is both negligent and fraudulent.
2. “One study found that among people who had recovered from COVID-19, 100% had S protein-specific CD4+ T cells in the circulation and 70% had S protein-specific CD8+ T cells in the circulation (Grifoni et al. 2020).”
SO NATURAL IMMUNITY DOES EXIST AND THE REGULATORS KNOW IT. If this is the case why are governments and employers pushing vaccines onto people who have already had Covid? This also begs the question why Pfizer never divided their trial into people who had Covid previously and those who didn’t.
3. “It was indicated by the sponsor that the BNT162b2 V8 and V9 variants have identical amino acid sequence with slight differences in their codon optimisation sequences for better antigen expression.”
THIS IS THE UNDERSTATEMENT OF THE CENTURY. The spike protein created by the vaccine is not the same as the same as the spike protein created by the virus. Those slight differences included adding proline genes, replacing pseudo-uridine with uridine and adding adenine to the pony-tail of the genetic sequence. This had the impact of increasing the stability of the synthesised spike protein, increasing the productive capacity of the mRNA and helped the spike protein evade the innate immune system. Long story short, rather than deattenuate the virus with a weaker antigen the vaccine actually delivers a much stronger antigen. This is not what vaccines are supposed to do.
4. “No dedicated immunotoxicity study was conducted. An in vitro study on stimulation of cytokine release in human PBMC cells provided inconclusive results….. Thus, autoimmune diseases are a potential risk of the vaccine. This is addressable by the ongoing 2-year clinical studies.”
Inconclusive is not satisfactory. Given autoimmune disease is an acknowledged risk of the disease then it is completely unacceptable that this risk would be tolerated in any circumstances let alone a global rollout.
5.”There is limited experience with use of COMIRNATY in pregnant women. Animal studies combined fertility and developmental toxicity study in rats did not show vaccine-related harmful effects on embryofetal development.”
The original document (see comments) said “A combined fertility and developmental toxicity study in rats showed increased occurrence of supernumerary lumbar ribs in fetuses from COMIRNATY treated female rat.” The TGA originally allocated pregnancy category B2 (studies in animals are inadequate) in their assessment but then upgraded to B1 (studies in animals have not been shown evidence of an increased occurrence of fetal damage) BY SUPRESSING A DOCUMENTED FINDING OF PRECLINICAL DATA.
6. “Antibodies and T cells in Rhesus macaques declined quickly after 5 weeks after the second dose of BNT162b2 (V9) raising long term immunity concerns. Rhesus macaques weigh around 10kg and were given 100ug, over three times more than what humans are given.”
Given these results why did authorities claim that the Pfizer vaccine would provide long lasting protection when a larger dose in a smaller animal had such an insignificant impact.
7. “There are no repeat dose or reproductive toxicity studies specifically with the novel excipients. The excipient is the Lipid Nanoparticle that encases the mRNA carrying the spike protein.”
So not only were the impacts of the spike protein unknown, there was unsatisfactory testing of the vehicle carrying the active ingredient.
8. “The toxicity of the LNP formulation and novel excipients ALC-0159 and ALC-0315 was assessed in one species as part of the repeat dose study with the vaccine. Neither the mRNA nor the lipid excipients of the LNP formulation are expected to have genotoxic potential. However, the potential of the LNP or the vaccine formulation for complement activation or stimulation of cytokine release was not adequately assessed in nonclinical studies. Further investigation (i.e., analysis of complement activation and cytokine stimulation) is recommended unless this particular concern is addressed by clinical data.”
So the cytokine reaction (i.e. the immune system) to the vaccine was not adequately assessed in animals or humans. This statement and subsequent approval of the vaccine beggar’s belief.
9. “Short term protection studies, lack of pharmacokinetic data for the S antigen-encoding mRNA (BNT162b2 V9), suboptimal dosing interval in the repeat dose study, lack of repeat dose toxicity studies in a second species and genotoxicity studies with the novel excipients, and lack of studies investigating potential for autoimmune diseases were noted. However, these deficiencies are either adequately justified by the Sponsor or addressable by clinical data.”
This paragraph summarises the prior points but is then dismissed because the TGA relied on the word of the sponsor, one of the biggest convicted corporate criminals in history. Furthermore, note the reliance by the TGA on clinical data rather than trials. They did not apply the same standard to Ivermectin which showed anti-viral properties in clinical studies but has been repeatedly dismissed by the TGA.
10. “P2 S antigen expression was demonstrated in HEK293 cells (human embryonic kidney cells) in vitro.”
So the only testing in the laboratory on the spike protein was with kidney cells not cells from the deltoid muscle which is where the vaccine is supposed to express the spike protein.
11. “BNT162b2 (V9) also induced cellular immune responses in mice and monkeys.”
Inducing an immune response isn’t the same as inducing a sterilising immune response. i.e. just because the vaccine produced antibodies doesn’t mean those antibodies actually destroy the virus in humans. It’s a question of degree and that question isn’t answered in clinical studies.
12. “Monkeys are not a good animal model of severe COVID 19 diseases in humans.”
This begs the questions as to why the Pfizer used monkeys along with rats.
13. “The TH1-biased response observed in mice and monkeys suggests low risk of antibody-dependent enhancement (ADE) and vaccine-associated enhanced respiratory disease (VAERD).”
What exactly does low risk mean? Is there 1% risk or 25% risk. When the vaccine is being rolled out to billions of people percentages matter. Furthermore, given such a risk why are boosters being rolled out without adequate testing, as cumulative doses will only increase these risks.
14. “Limited safety pharmacology parameters e.g. body temperature were investigated in the toxicity study, in accordance with the WHO guideline on nonclinical evaluation of vaccines.”
Why is the TGA following WHO guidelines which are conflicted by the fact that one of its biggest donors has significant investments in vaccines? I.e. Bill Gates.
15. “There are no data on the kinetics of BNT162b2 mRNA degradation. In mice injected with the luciferase mRNA, the absence of expressed protein by 9 days after dosing indicates that mRNA has been degraded.”
In other words, it is not known how long mRNA stays in the human body. This contradicts what the TGA said in estimates that indicated mRNA broke down in a matter of hours not days.
16. “The distribution of lipid nanoparticles encapsulating mRNA encoding luciferase was investigated by monitoring of a radiolabelled lipid-marker after a single IM injection to Wistar rats…….. In summary, the limited pharmacokinetic studies indicate that the vaccine LNP formulation is expected to deliver the mRNA effectively in vivo and the antigen expressed mainly at the injection site, liver and probably in draining lymph nodes. The limited studies showed slow elimination of ALC-0315 and retention in liver, and complete elimination of ALC-0159 in 14 days, with the latter eliminated in faeces most likely by biliary excretion.”
The words “limited pharmacokinetic studies”, “slow elimination” and “probably” do not elicit a high degree of confidence and lack specificity. This uncertainly is further reinforced by the fact rats are hardly adequate substitutes for humans. Retention in the liver requires further investigation especially in light of the hepatitis cases being reported in the northern hemisphere.
17. “In rats dosed with 100 μg BNT162b2 (V8), in addition to the findings for the V9 variant, local reactions increased with repeated dosing.”
If evidence exists of reactions increasing with repeated dosing why are boosters being rolled out with no testing?
18. “Macroscopic pathology and organ weight changes were also similar for the two variants and included increased size of draining (iliac) lymph nodes and increased size and weight of spleen. Treatment related microscopic findings were seen at the injection sites and in surrounding tissues (mixed cell inflammation, mostly neutrophils), draining lymph nodes (hypercellularity of germinal centre and increased plasma cells, mostly plasmablasts), bone marrow (hypercellularity of haematopoietic cells, primarily myeloid cells), spleen (increased haematopoiesis and germinal centre), and liver (vacuolation of hepatocytes in the portal region), consistent with immune responses and inflammatory reactions except for hepatocyte vacuolation (minimal in severity), probably lipid vacuoles. Clinical pathology findings (except for serum globulin), and spleen (haematopoiesis), bone marrow and liver lesions were fully reversed after the 3-week recovery phase. Injection sites, spleen (increased germinal centre) and lymph node findings persisted during the 3-week recovery phase (both variants V9 and V8), and body temperature remained at an increased level at the end of the 3- week recovery phase (for the V8 variant).”
The vaccine caused inflammation and other side effects in multiple organs, including lymph nodes and bone marrow for up to three weeks. This begs the question – won’t the immune system then be more vulnerable to the virus if it has been weakened by the vaccine and echoes the sentiments of Geert Vanden Bossche who says you should never vaccinate the population in the middle of a pandemic.
19. “No genotoxicity studies were conducted for the vaccine. This is in line with relevant guidelines for vaccines.”
This is known as regulatory arbitrage. The guideline for vaccines were developed in 2005 when gene technology was in its infancy. For Pfizer to be using this as excuse to not test a completely new form of technology is completely negligent from a quality assurance perspective.
20. “Carcinogenicity studies were not conducted. This is acceptable based on its duration of use. The novel lipid excipients are not expected to be carcinogenic based on the low exposure, duration of exposure, absence of structure alerts for mutagenicity.”
Yet again “not expected” lacks specificity. Unless tests are conducted how would Pfizer know what to expect. “Duration of use” is also not qualified. Given that up to four shots have been rolled out to date, duration of use/exposure is clearly getting longer and therefore the risks increases with every extra dose.
21. “It is unknown whether BNT162b2 is excreted in human milk.”
If this is case why are pregnant and breastfeeding women being vaccinated?
