Vaccine Manufacturing Process

Methodological Considerations Regarding the Quantification of DNA Impurities in the COVID-19 mRNA Vaccine Comirnaty

In Abstract:  “when quantifying the total DNA content in the final product, we must observe that, in addition to the mRNA active ingredient, DNA impurities are also encased in lipid nanoparticles and are therefore difficult to quantify.”

In Conclusion The available information and data indicate that the ready-to-use mRNA vaccine Comirnaty contains DNA impurities that exceed the permitted limit value by several hundred times and, in some cases, even more than 500 times, and that this went unnoticed because the DNA quantification carried out as part of batch testing only at the active substance level appears to be methodologically inadequate when using qPCR, as explained above.

Review: N1-methyl-pseudouridine (m1Ψ): Friend or foe of cancer?

From Abstract:  Mounting evidence indicates that these vaccines, like many others, do not generate sterilizing immunity, leaving people vulnerable to recurrent infections. Additionally, it has been discovered that the mRNA vaccines inhibit essential immunological pathways, thus impairing early interferon signaling. Within the framework of COVID-19 vaccination, this inhibition ensures an appropriate spike protein synthesis and a reduced immune activation. Evidence is provided that adding 100 % of N1-methyl-pseudouridine (m1Ψ) to the mRNA vaccine in a melanoma model stimulated cancer growth and metastasis, while non-modified mRNA vaccines induced opposite results, thus suggesting that COVID-19 mRNA vaccines could aid cancer development.

Vector vaccines have been shown to result in production of the antigen for years.  

Written by two Moderna Employees,  Eric Jacquinet and Dimitrios Bitounis and Maximillian Rogers

ABSTRACT “mRNA formulated with lipid nanoparticles is a transformative technology that has enabled the rapid development and administration of billions of coronavirus disease 2019 (COVID-19) vaccine doses worldwide. However, avoiding unacceptable toxicity with mRNA drugs and vaccines presents challenges. Lipid nanoparticle structural components, production methods, route of administration and proteins produced from complexed mRNAs all present toxicity concerns. Here, we discuss these concerns, specifically how cell tropism and tissue distribution of mRNA and lipid nanoparticles can lead to toxicity, and their possible reactogenicity. We focus on adverse events from mRNA applications for protein replacement and gene editing therapies as well as vaccines, tracing common biochemical and cellular pathways. The potential and limitations of existing models and tools used to screen for on-target efficacy and de-risk off-target toxicity, including in vivo and next-generation in vitro models, are also discussed.”

Lipid Nanoparticles migrate throughout the body quickly.  This was known in November 2020

“The concentrations of [3 H]-08-A01-C01 were greatest in the injection site at all time points, with levels peaking in the plasma by 1-4 hours post-dose and distribution mainly into liver, adrenal glands, spleen and ovaries over 48 hours”

University of Ulm finds contamination in Astra Zeneca. 

“The HCP content exceeded the 400 ng specification limit per vaccine dose, as set by the European Medicines Agency (EMA) for this vaccine, by at least 25-fold and the manufacturer’s batch-release data in some of the lots by several hundred-fold.”

Lipid Nanoparticles have been found to be effective in crossing the blood brain barrier.

Conclusion: Lipid based formulations can be designated as the current and future generation of drug delivery systems as these possess tremendous potential to bypass BBB and reach the target site due to their small size and ability to dodge the reticular endothelial system.

N1-methylpseudouridylation of mRNA causes +1 ribosomal frameshifting

(in other words, our bodies could be producing proteins.  See an explanation of what that means HERE 

Read comments by other doctors and researchers on this paper here: 

Read an open letter about this here