Coronavirus Disease-19 Vaccines Best Reflect Effective Pharmaceuticals

Cosentino, Marco; Ferrari, Marco; Marino, Franca

doi:10.1007/s11481-021-09998-z

Cited by 6 publications

(3 citation statements)

References 9 publications

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“…In summary, we have highlighted the pitfalls of having considered until now COVID-19 mRNA vaccines as just conventional vaccines, and we have indicated the preclinical, clinical and post-marketing safety assessments that are most urgently needed. COVID-19 mRNA vaccines are actually pharmaceutical drugs, and consequently their pharmacokinetics and pharmacodynamics, and possibly also their pharmacogenetics, must be properly characterized [89] to provide a solid background of knowledge for their rational and targeted use, thus stopping "playing dice" with these products due to the misbelief that the same vaccine at the same dose is good for everyone, and that adverse effects occur just by chance. A correct, rigorous and complete evaluation of COVID-19 mRNA vaccines will be of critical importance for reassuring the public about their safe and effective use, eventually overcoming vaccine hesitancy.…”

Section: Discussionmentioning

confidence: 99%

Understanding the Pharmacology of COVID-19 mRNA Vaccines: Playing Dice with the Spike?

Cosentino

Marino

2022

IJMS

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Coronavirus disease-19 (COVID-19) mRNA vaccines are the mainstays of mass vaccination campaigns in most Western countries. However, the emergency conditions in which their development took place made it impossible to fully characterize their effects and mechanism of action. Here, we summarize and discuss available evidence indicating that COVID-19 mRNA vaccines better reflect pharmaceutical drugs than conventional vaccines, as they do not contain antigens but an active SARS-CoV-2 S protein mRNA, representing at the same time an active principle and a prodrug, which upon intracellular translation results in the endogenous production of the SARS-CoV-2 S protein. Both vaccine-derived SARS-CoV-2 S protein mRNA and the resulting S protein exhibit a complex pharmacology and undergo systemic disposition. Defining COVID-19 mRNA vaccines as pharmaceutical drugs has straightforward implications for their pharmacodynamic, pharmacokinetic, clinical and post-marketing safety assessment. Only an accurate characterization of COVID-19 mRNA vaccines as pharmaceutical drugs will guarantee a safe, rational and individualized use of these products.

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Section: Discussionmentioning

confidence: 99%

Understanding the Pharmacology of COVID-19 mRNA Vaccines: Playing Dice with the Spike?

Cosentino

Marino

2022

IJMS

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“…This hypothesis has been circulated by several of us [3,4] for some years already. It is supported by the paper by Adhikari and collaborators in the following way:…”

Section: The S Protein Of Various Cov's May Not Play a Critical Role ...mentioning

confidence: 99%

Comment on Adhikari et al. (2024): their findings invalidate the postulated mechanism and effects of COVID-19 mRNA vaccines and their predominant efficacy measures

Mueller

2024

Preprint

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A recent paper in Front. Immunol. finds that among the adult patients admitted to Ohio State University hospital with acute respiratory failure and various comorbidities between 05/2020 and 11/2022, in those diagnosed with COVID-19, the mortality rate among the vaccinated was about twice that of those who were not. To account for this unexpected finding, Adhikari and colleagues evaluated antibody (Ab) responses to SARS-CoV-2 infection/vaccines and those to common cold coronaviruses. Some of the results reported seem incomplete or even contradictory. Here, an independent logical analysis of the data provided shows that many of the believed mechanisms of action of the mRNA vaccines are not substantiated and instead give rise to several hypotheses. In particular, the most potent mediators of protection are likely not those commonly described. The conclusions and hypotheses of this analysis are analogous to a recent publication in Science Translational Medicine which revealed that heterotypic immunity from prior SARS-CoV-2 infection, but not COVID-19 vaccination, is associated with lower endemic coronavirus (CoV) incidence. Overall, any survival protection against a wide array of CoVs seems to be facilitated by natural and broad immune responses, even though this is commonly falsely attributed to the injections. The core mechanisms and effects of mRNA vaccines, as widely believed, are contradicted by the published clinical findings by Adhikari et al., and the commonly used measures to evaluate their effectiveness are unwarranted.

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“…For example, it was established long ago that distinct tissues widely differ in the efficiency of protein synthesis, but no one so far assessed whether and to what extent this is relevant for the efficacy and safety of mRNA vaccines [ 13 ]. Therefore, we further recommend careful characterization of COVID-19 vaccines with regards to systemic disposition, including organs and tissues where S protein production occurs and interindividual variability in local protein synthesis efficiency, to provide a rational basis for dose individualization and to identify subjects at risk for adverse reactions due to either vaccine-induced S protein production in vulnerable sites, excessive S protein production, or both [ 14 ].…”

Section: Concluding Remarks and Future Perspectivesmentioning

confidence: 99%