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Published recently in MDPI, Italian medical researchers Marco Cosentino and Franca Marino, both teachers at the University of Insubria’s Center for Research in Medical Pharmacology, express the opinion that COVID-19 vaccines represent pharmaceutical therapeutics more so than traditional vaccines.
Why? The Italian authors argue that the COVID-19 mRNA vaccines do not contain antigens but rather an active SARS-CoV-2 S protein mRNA, representing both an active principle and a prodrug. These authors argue that “intracellular translation results in the endogenous [internal cause or origin] of the SARS-CoV-2 S protein.” They suggest that both the ”vaccine-derived SARS-CoV-2 S protein mRNA” as well as the ensuing S protein represent a “complex pharmacology” thereby undergoing “systemic disposition.”
Thus, the author's opinion piece leads to a provocative but important proposal—the COVID-19 mRNA vaccine should be classified as a pharmaceutical drug because of the more “straightforward implications” involving associated “pharmacodynamic, pharmacokinetic, clinical and post-marketing safety assessment actions.
The authors conclude with what this media considers a critically important point: “Only an accurate characterization of COVID-19 mRNA vaccines as pharmaceutical drugs will guarantee safe, rational, and individualized use of these products.” A bombshell of an opinion: time to classify the mRNA vaccines as pharmaceutical therapeutics.
Importantly, despite the fact that a significant limitation of mRNA gene therapy includes an inadequate understanding of how to target specific organs and cells for protein expression, the matter has not been studied by government and industry. Yet the systemic biodistribution and disposition of the COVID-19 mRNA vaccines to date have been considered by the medical establishment as a non-issue. But it most certainly argues these two Italian medical researchers, and mounting evidence points to this concerning conclusion.
What’s the context for the author’s argument?
Fundamental to the author’s argument is the assumption that there emerged a considerable delta between what health agencies, regulators, and industry (pharma) claimed about the COVID-19 mRNA vaccines versus how they actually performed in use.
What is that delta? According to the report’s authors represented by corresponding author professor Marco Cosentino, the assumption is that the mRNA vaccines were “intrinsically safe “and that compared to conventional vaccines post “intramuscular injection, most of the dose would remain in the muscle, and the rest would drain through the lymphatic system, being eventually captured by antigen-presenting cells and B cells and undergoing complete elimination in a few tens of hours at the most.”
Consequently, argues Professors Marco and Marino, “the public was explicitly reassured by influential blogs as well as by academic institutional web pages that these products were not expected to exhibit any relevant systemic disposition and that the resulting S protein would remain attached to the surface of the cells and would not be released in the bloodstream and tissues to encounter ACE2 receptors and eventually induce organ damage.”
Yet as countless case series, reports, and even real-world data present, the authors report, “it became clear that this was not the case.”
But what evidence do the Italian researchers put forth for their argument?
They point to evidence for systemic biodistribution of the COVID-19 vaccine-induced S protein in vaccinated subjects which was a topic of concern in the spring of 2021 when through freedom of information act actions TrialSite reported, for example, on evidence of spike protein biodistribution in lab animals based on preclinical studies involving the Pfizer-BioNTech vaccine known as BNT162b2.
Cosentino and Marino argue that first this evidence was documented in the blood of 11 out of 13 subjects as early as the first day of injection of Moderna’s mRNA-1273 up to 150 pg./mL for about two weeks post-injection.
The authors report a case report of a woman who suffered from thrombocytopenia due to vaccination with mRNA-1273 involving 10mg/ml vaccine-induced S protein levels in plasma 10 days post-vaccination, almost 100 times higher than those reported before. According to the authors, “suggesting excessive vaccine-induced production of S protein as a determinant of vaccine toxicity.” See the link.
Then the authors point out that “both vaccine mRNA and vaccine-induced S protein were shown in axillary lymph nodes up to 60 days after the second dose of both Moderna and BioNTech-Pfizer vaccines.” See the link. The authors point out the evidence that endogenous production of S protein post-vaccination can “occur for much longer than previously thought.”
Additionally, this concerning evidence surfaced in another study: “The S protein has been so far identified in endomyocardial biopsies of patients with myocarditis up to nearly two months following COVID-19 vaccination. This evidence has also been presented in “circulating monocytes of patients with post-acute sequelae of COVID-19 (PASC)-like symptoms following COVID-19 vaccines as reported by a U.S. based study.
TrialSite has reported on numerous case reports involving the surfacing of the spike protein as do the Italian researchers in this case “in the vesicular keratinocytes and endothelial cells in the dermis in a patient who had persistent skin lesions due to varicella zoster virus (VZV) reactivation over three months after COVID-19 vaccination. See the link.
Also, a case report in Vaccines reveals the S mRNA was present in the right deltoid and quadriceps muscles of a woman with myositis one month after injection of the BioNTech -Pfizer COVID-19 mRNA vaccine into the left deltoid muscle.
The authors conclude, “Taken as a whole, evidence strongly supports the possible link between inappropriate expression of S protein in sensitive tissues and subsequent tissue damage.”
What are the implications for adverse reactions?
The Italian authors indicate that based on a comprehensive review of literature in regard to the role of COVID-19 mRNA vaccine-induced S protein in adverse effects associated with vaccination, they argue “that the production of S protein induced by COVID-19 mRNA vaccines may well compare to the estimated production during SARS-CoV-2 infection.”
Conclusion
In the recent opinion piece, Consentino and Marino argue that the role of the S protein in adverse events post-COVID-19 mRNA vaccination is real, thus recommending more “appropriate pharmacological approaches” helping to better characterize the mRNA vaccines. The goal: generate guidance to help direct the most “rational and individualized use.”
Because the Italian medical researchers argue that unpredictable inducement in at least select individuals “excessive production of S protein, for too long and/or in inappropriate tissues and organs” the topic most definitely merits more study.
The COVID-19 mRNA vaccines “could be classified as type 1 prodrugs since they undergo intracellular conversion.” Yet where this conversion occurs in the tissue is “uncertain, since the catalytic mechanism leading to protein synthesis is common to all the cells in any tissues and organs, with the notable exception of erythrocytes, which do not have ribosomes, but including, for example, platelets, which maintain the ability to synthesize proteins thanks to a small pool of ribosomes inherited from their precursor megakaryocytes.”
Thus, the authors argue that this “Translation of the SARS-CoV-2 S protein mRNA into active S proteins could therefore in principle occur anywhere in the body, as also suggested by the ability of the lipid nanoparticle–mRNA formulations of both BioNTech–Pfizer and Moderna preparations to reach virtually any organ and tissue in preclinical biodistribution studies in rodents.”
