Weird Tales from the TGA By Brian Simpson
Now this is unusual. Australia’s Therapeutic Goods Administration (TGA) made a report from 2021 available to the public. The title is gobbledydook technical, cited below, but the take home message is that this document was not released at the time, the summit of the Covid freak-out. What the Pfizer documents showed was that “antibodies and T cells in monkeys declined quickly after 5 weeks after the second dose of BNT162b2 (V9), raising long-term immunity concerns.” What this means is that it was known that there would be a likely decline in the effectiveness of the vax, but this information was not released at the time. No doubt if material like this was fairly discussed, some people might have thought for a moment about the vax, and committed the unforgivable sin of vaccine hesitancy. But, not to worry, the system has already moved to force people to be vaxxed, or be sacked. After lockdowns, people were too battle-weary to resist the tyranny any way. And the rest is history.
“Recently, Australia’s Therapeutic Goods Administration (TGA) made a report from 2021 available to the public. Titled “Nonclinical Evaluation Report BNT162b2 [mRNA] COVID-19 Vaccine (COMIRNATYTM)” the document provides inputs from the preclinical work involving the Pfizer-BioNTech mRNA vaccine BNT162b2 (Comirnaty) via Pfizer Australia Pty Ltd. A bombshell actually, the TGA, the agency that is supposed to “safeguard and enhance the health of the Australian community through effective and timely regulation of therapeutic goods” seemingly let the pharmaceutical company in this case dictate the risk-benefit analysis. At the height of the pandemic and the onset of the mass COVID-19 vaccination rollout starting February 22, 2021, the data in this document wasn’t shared with the public. But why not? Would the data (or lack thereof) associated with this report lead to more vaccine hesitancy?
Background
Summarizing the artifact used for gaining emergency access to the Australian market during the pandemic, the pharmaceutical sponsor shares more details as to the Comirnaty vaccine made in lipid nanoparticle (LNP) formulation [BNT162b2 (V9)] indicated for “active immunization to prevent COVID-19 disease caused by SARS-CoV-2 virus, in individuals 16 years of age and older.”
Asking for provisional authorization for the administration of two doses of 30 μg of mRNA/0.3 mL per dose given 21 days apart intramuscularly (IM), Pfizer communicates in the document that they have “generally conducted adequate studies on pharmacology and toxicity (GLP compliant repeat dose and developmental and reproductive toxicity studies) with BNT162b2 (V9)."
The company [Pfizer] acknowledges, “Limited pharmacokinetic studies were conducted with the LNP formulation and two novel lipid excipients (ALC-0159 and ALC-0315). Yet the product was found to be immunogenic in non-clinical studies in mice, rats and rhesus macaques." Furthermore, the mRNA vaccine “induced humoral and cellular immune responses in mice and monkeys.”
This document, published right during the time that mass COVID-19 vaccinations commenced, yet was suppressed from the public, acknowledges that “antibodies and T cells in monkeys declined quickly after 5 weeks after the second dose of BNT162b2 (V9), raising long-term immunity concerns.”
TGA does report that when infecting monkeys with SARS-CoV-2, the virus behind COVID-19, the Pfizer COVID-19 vaccine did protect the non-human primate subjects at 55 days after the second dose. TGA communicates that Pfizer came to this assessment by measuring viral RNA load and radiographic lung lesions. However, the non-human primate subjects (monkeys) received 100 μg, markedly higher than the proposed human dose at the time of 30 μg.
Problematically, the TGA reports that Pfizer found comparable microscopic lung inflammation observed in both “challenged and control immunized animals after the peak of infection (Days 7/8). Other limitations acknowledge—Pfizer didn’t conduct studies on the vaccine for protection on older animals with SARS-COv-2 infection or for that matter, duration of protection post administration of the vaccine.
Moreover, given the preclinical animal studies were short studies, “long-term immunity was not assessed.” According to TGA, “The sponsor indicated that long-term immunity would be addressed by human data.”
Shockingly, Pfizer reported to TGA that there was no data on the distribution and degradation of the spike protein produced via the mRNA vaccine! At that time, the TGA in defense of the company’s woefully inadequate data declared:
“A whole-body imaging study with a surrogate, luciferase-expressing mRNA indicates that the vaccine LNP formulation is expected to deliver the mRNA effectively in vivo, the mRNA and translated antigen protein are mainly localized at the injection site, distributed in the liver and likely draining lymph nodes, and nearly completely degraded in 9 days.”
This was completely off the mark. Yet fact checkers to this date do not acknowledge the accumulating evidence that the spike protein may circulate and present in various organs of the body in some cases months after the COVID-19 vaccination.
With limited data, the TGA attempted to bolster the Pfizer case, for example, elucidating, “The limited studies showed slow elimination of ALC-0315 and retention in the liver, and complete elimination of ALC-0159 in 14 days, with the latter eliminated in faeces most likely by biliary excretion. Both lipids are also eliminated by amide or ester hydrolysis.”
Overall safety was justified with rat studies administered 3 IM doses once weekly at 30 μg/dose, ~200 times the clinical dose on a μg/kg basis—the animal subjects showed injection site inflammation, clinical pathology (increases in white blood cells, basophils, eosinophils, neutrophils, large unstained cells, fibrinogen, and acute phase proteins), and tissue pathology(hypercellularity of draining lymph nodes, spleen and bone marrow), consistent with immune stimulation and inflammation responses as well as minimal vacuolation of portal hepatocytes without evidence of liver injury.
The TGA declared, “All effects were either partially or fully reversible after 3 weeks of recovery. However, the dosing interval (one week) was not ideal given the immune response peaks 2-3 weeks after dosing, and the clinical dosing interval is 3 weeks.”
TGA following Pfizer’s rationale communicated that “another repeat dose study in animals” wasn’t needed. Pushing forward, presumably due to fear of even worse outcomes associated with the COVID-19 pandemic, the TGA conveyed that the “shortcomings” of the current toxicity studies “should not preclude approval of the vaccine.”
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