Potential Health Risks of mRNA-based Vaccine Therapy

Karina Acevedo Whitehouse Ph.D ,Roxana Bruno Ph.D – DOI: 10.22541/au.165365747.71179012/v1

Therapeutic applications of synthetic mRNA were proposed more than 30 years ago and are currently the basis of one of the vaccine platforms being used on a large scale as part of the public health strategy to control COVID-19. To date, there are no published studies on biodistribution, cellular uptake, endosomal escape, translation rates, functional half-life and inactivation kinetics of synthetic mRNA, rates and duration of vaccine-induced antigen expression in different cell types.

Furthermore, despite the assumption that there is no possibility of genomic integration of therapeutic synthetic mRNA, only one recent study has examined the interactions between vaccine mRNA and the genome of transfected cells, and reported that an endogenous retrotransposon, LINE-1, is not silenced after mRNA entry into the cell, leading to reverse transcription of full-length vaccine mRNA sequences and nuclear entry.

This finding should be a major safety concern, given the potential for synthetic mRNA-driven epigenetic and genomic modifications.

We propose that in susceptible individuals, cytosolic elimination of modified synthetic nucleotides (nms-mRNA) is prevented. The sustained presence of nms-mRNA in the cytoplasm deregulates and activates endogenous transposable elements (TEs), causing some of the mRNA copies to be reverse transcribed.

The cytosolic accumulation of nms-mRNA and the reverse-transcribed cDNA molecules activates the RNA and DNA sensory pathways. Their simultaneous activation initiates a synchronised innate response against foreign nucleic acids, triggering the production of type I interferon and pro-inflammatory cytokines that, if unregulated, leads to autoinflammatory and autoimmune conditions, while activated TEs increase the risk of insertional mutagenesis of the reverse-transcribed molecules, which can alter coding regions, increase the risk of mutations in tumour suppressor genes and lead to sustained DNA damage.

Susceptible individuals would then be at increased risk of DNA damage, chronic autoinflammation, autoimmunity and cancer.

In light of the current mass administration of nmsRNA vaccines, it is essential and urgent to fully understand the intracellular cascades initiated by cellular uptake of synthetic mRNA and the consequences of these molecular events increase the risk of mutations in tumour suppressor genes and lead to sustained DNA damage.

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