an Experimental Concoction

First posted online: 19 May 2022

With #AllTheRisks from all the publicly known ingredients in Pfizer’s experimental concoction, why should anyone be pressurised, let alone mandated, to experiment with systemic exposure to an uncharacterised foreign and toxic protein (spike) for an uncontrolled duration?

The active pharmaceutical ingredient has been mismarketed as mRNA for spike protein’s genetic code. More correctly, it is lab-synthesised nucleoside-modified RNA, modRNA. Uridine has been replaced by N1-methylpseudeouridine with unknown safety consequences. Experimental.

To help the modRNA evade innate immune recognition as viral RNA, it has been artificially humanised by insertion of human globin protein in the 3’ and 5’ untranslated regions. It has also been codon optimised in the lab by GC-enrichment of the spike protein genome.

In developing gene therapies, it has been observed that replacing rare with common codons results in prolonged protein expression. Even if synonymous mutations are chosen that do not alter expressed proteins, safety concerns were known prior to the genetic vaccine rollout.

September 2019. The FDA’s Dr Alexaki: “although most people think of codon optimization as harmless… a single synonymous mutation may be associated with disease and in many cases the reason is unknown. In other cases, the rate of translation has been implicated.”

A recent preprint co-authored by the late Nobel Prize winner Prof Montagnier highlights a prion region in the wild-type (and hence vaccinal) spike protein, associated with 26 cases of the neurological condition CJD, of novel aggression, including sudden death in 8 cases.

Crucially, the paper suggests GC-enrichment may exacerbate the prion-like toxicity of the spike protein. Biotechnology might be able to exploit natural processes (like endocytosis and ribosomal translation) to manufacture foreign protein, but what is the added toxic cost?

The toxicologically uncharacterised novel SARS-CoV-2 spike protein has had its genetic code further artificially modified. Known from MERS (2014), it’s been “stabilised” in its prefusion conformation via a double proline “2P” amino acid mutation to promote immunogenicity.

According to a leaked Pfizer purchase agreement, the modRNA acceptance criteria is paltry: 50% integrity. With such a wide margin of error, how much double stranded RNA is residual due to contamination with plasmid/template DNA? How much aberrant protein is expressed?

Depending on a given batch’s purity, a smorgasbord of too short, too long and other aberrant spike proteins could be synthesised. Double-stranded RNA has been implicated in immune-inflammatory responses, even suggested in one paper as causing vaccine-induced myocarditis.

Based on a 2005 WHO vaccine report, the MHRA justified skipping safety studies on chemical toxicity, carcinogenicity, and genotoxicity (genetic damage). Substantial in vitro and in silico evidence now raises serious red flags on the spike protein alone in all these areas!

With only sketchy data on the two novels lipids metabolising in rats and no studies in humans, risk is high. Novel ionisable cationic lipid ALC-0315 conveys a positive charge to deliver the genetic cargo to the cytosol. Until COVID, cationic lipids were too toxic to use.

Toxic PEGylated lipid ALC-0159 forms a stearic barrier to prevent LNP aggregation. A 2019 study on 200 blood donors found a 97.5% prevalence of IgM/IgG anti-PEG antibodies, which may be recalled against the LNPs, impairing efficacy or causing anaphylaxis, on repeat doses.

Tetrahydrofuran, a suspected carcinogenic agent according to the European Chemicals Agency, is a residual solvent of ALC-0159. We’re not entitled to know the purity of ALC-0159, so we don’t know how many other suspected carcinogens make their way into the final product.

DSPC is a naturally occurring phospholipid, but Pfizer manufacture it according to “in house” specifications, so it again does not comply with the European Pharmacopeia. Again, we are not privy to know its purity profile nor its acceptance criteria.

Even the water for injection is shadowy. Its weight is given as “proprietary” in the Safety Data Sheet. A 2021 recall notice on WFI lot manufactured by Hospira, a Pfizer subsidiary, details a “visible particulate” found that could cause “pulmonary emboli, and infarction.”

Nobody should be unaware of #AllTheRisks that permeate the manufacturing processes, not least modifications to the very spike protein drug substance. No wonder Pfizer’s modRNA persists in lymph nodes for up to 8 weeks and spike protein freely circulates for 4 months!

MHRA's public assessment report for Pfizer's BNT162b2

FDA's Dr Alexaki presenting risks of codon optimisation