Pfizer Used Dangerous Assumptions, Rather than Research, to Guess at Outcomes

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At the launch of widespread mass inoculation of the public with Pfizer’s mRNA vaccine, BNT162b2, media, physicians’ spokespeople,  and government officials communicated widely that the injected drug would be retained at the injection site muscle tissue and in local lymph nodes. The components were supposed to be metabolized in a day or so, leaving only induced SARS CoV-2 Spike antigen to evoke a therapeutic immune response. A short pulse of drug effect would be followed, they claimed, by limited production of Spike antigen. 

However, newly released internal Pfizer documents show that this is not true.  In fact, the injection causes widespread distribution of the material in tissues and this distribution persists for at least two days, and probably much longer. These facts are the exact opposite of what was publicized.

A cluster of FDA-released Pfizer documents — “Final Report: A Tissue Distribution Study of a [3H]-Labelled Lipid Nanoparticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats”[https://www.phmpt.org/wp-content/uploads/2022/03/125742_S1_M4_4223_185350.pdf], 2.4 NONCLINICAL OVERVIEW [https://www.phmpt.org/wp-content/uploads/2022/03/125742_S1_M2_24_nonclinical-overview.pdf], “MODULE 2.6.5. PHARMACOKINETICS TABULATED SUMMARY”

[https://www.phmpt.org/wp-content/uploads/2022/03/125742_S1_M2_26_pharmkin-tabulated-summary.pdf] and the heavily redacted  report “R&D STUDY REPORT No. R-20-0072 – EXPRESSION OF LUCIFERASE-ENCODING MODERNA AFTER I.M. APPLICATION OF GMPREADY ACUITAS LIPID NANOPARTICLE FORMULATION “[https://www.phmpt.org/wp-content/uploads/2022/03/125742_S1_M4_4223_R-20-0072.pdf] — all examine tissue distribution of Pfizer’s mRNA vaccine BNT162b2. These documents will be addressed in this report.

Pfizer Study 185350,” Final Report: A Tissue Distribution Study of a [3H]-Labelled Lipid Nanoparticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rat”, is one of 21 preclinical Prizer studies involving mice, rats and rhesus macaque non-human primates. Study No. 185350 (Sponsor Reference ALC-NC-0552) was summarized in Pfizer’s “2.4 Nonclinical Overview” and was separately published as a Final Report dated September 24, 2020.

Contained in that document is the following identification of the source:

Test Facility Study No. 185350 REDACTED

SPONSOR:
Acuitas, 
6190 Agronomy Road, Ste. 402, 
Vancouver, V6T 1Z3 Canada
Sponsor Reference No. ALC-NC-0552

This study was made up  of 42 male and 21 female Wistar Han rats. These rats were injected with 50 or 100 micrograms of BNT162b2 mRNA/LNP (lipid nanoparticle) product labelled with a radioactive tracer material, 3H. Then the rats were sacrificed at intervals of 0.25 hours (15 minutes); 1 hour; 2 hours; 4 hours; 8 hours; and then at 1 and 2 days. 

The results of 21 male and 21 female sacrificed rats are presented.

The 100-microgram dose was associated with loss of weight and apparent toxicity in two animals. Unfortunately, the full results of the 100-microgram dose were not presented at all. [https://www.phmpt.org/wp-content/uploads/2022/03/125742_S1_M4_4223_185350.pdf, p. 11.]

by Robert W. Chandler, M.D., M.B.A

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