The modus operandi and effect of mRNA vaccines - are we barking up the wrong tree?

Preprint published

Over the years, as I have been studying the (COVID-19) mRNA “vaccines,” it has become increasingly clear that their very foundations of how they are said to evoke immunity have serious cracks. The simple computer-generated cartoons of the vaccine antigen triggering an adaptive immune response have proven far too simplistic, unsubstantiated, and wrong.

I am happy to announce the completion of some major work in this regard which was just published as a preprint. Well, I should say, it’s merely the completion of the first step. What I have as a preprint is much too long for a journal publication (any suggestions of where to submit are welcome). I do not expect the establishment will appreciate me challenging the very basis of those “vaccines,” lol. Yet, my hypothesis is supported by tons of studies and paradoxical findings, which I approached with a rational multi-disciplinary view.

Here is the abstract (emphasis added):

The modus operandi of mRNA vaccines has been celebrated for its simplicity but not withstood scientific scrutiny. Here, a multi-disciplinary analysis of published literature identifies that even the most foundational pillars of the presumed mRNA vaccine immunity are unfounded and rely on unproven modeling. Several reports have also identified gaps in some of the traditional immunity frameworks the mRNA vaccines are thought to rely on and other unexpected immune mRNA vaccine responses that cannot be aligned with the believed modus operandi.

Independently, extracellular vesicles (EVs) such as exosomes have emerged not only as potent carrier molecules of biological activities but also as immune-instigating agents. Informed by some of the main inconsistencies and gaps and complemented by startling features of EVs, it is suggested here that those vesicles may play a substantial role in shaping the immune responses of the mRNA vaccine platforms. Whereas synthetic EVs are also pursued as “superior carriers” of novel mRNA vaccines, their natural counterparts, both from injected humans or animals, as well as their microbiota, create a complex network of cell-to-cell and inter-kingdom communication, allowing for the exchange of immune-instigating agents and activities that also may shuttle vaccine-derived material and products across traditionally impermeable barriers or into the cell nucleus. The cargo of these carriers includes the injected mRNAs, short RNA byproducts, and other contaminating genetic material, including DNAs, as well as (aberrant) protein products, lipids, and resulting antigens. Thereby, EVs can, for example, activate immune cells, themselves function akin to antigen-presenting cells and refine and modulate both innate and adaptive immune processes in numerous non-traditional ways. However, EV-engendered immune responses may be either a positive, negative, or complex combination of immune activation and down-regulation. Considering EVs as pivotal players of the immune reactions triggered or also maintained by mRNA vaccines can help explain some of the previous paradoxes that could not be resolved within the original or more recent models of their immune mechanisms. But it also raises serious concerns.

In all, this work gives strong evidence as to why we may be basing much of the entire framework of mRNA vaccines on an incomplete or even erroneous modus operandi. This has significant implications for academic vaccine analysis, safety assessment, and their clinical and environmental ramifications.

As for the first part, the foundational gaps related to the modus operandi of RNA vaccines, a short summary is given in Figure 1 below:

Figure 1: As confirmed by ample real-world experience, the modus operandi of RNA vaccines, as widely taken for granted (the central highlighted part), is much too simplistic and raises an increasing number of open questions and concerns (depicted outside the central part that has received the main focus) (Source: https://osf.io/preprints/osf/5dz3f_v1).

Even though they cannot be assumed to provide a complete explanation for the existing gaps and unknowns, human and microbial EVs may to a substantial degree shape the actual immune mechanisms triggered by the injections (summarized in Figure 2).

Figure 2: The assumed modus operandi of existing and emerging RNA vaccines (inside the central box) cannot be explained by traditional models of immune activation and maintenance. During the last few years, startling gaps and omissions have emerged. Existing (and new) mRNA platforms involve EVs, both implicitly and deliberately (depicted outside the central part that has received the main focus). Yet, how they shape immunity largely transcends the presumed model. The potential of EVs as immune-instigating agents and biological carriers both related to the injected organisms, their close contacts, offspring, and environment is largely unknown in the context of the mRNA platforms. (Source: https://osf.io/preprints/osf/5dz3f_v1)

I conclude with the following (emphasis added):

The involvement of EV-mediated immune reactions triggered by the mRNA-LNP platforms has previously not been adequately anticipated. Recent focus on EVs in the context of mRNA vaccines has been on their potential as endogenous or synthetically modified carriers. However, their capacity to induce immunity in the injected humans, animals, or exposed organisms may substantially overturn not only the vaccine-engendered immune response model but also the methods of how these platforms have been evaluated. As EVs can trigger or impact immune responses directly and beyond the traditional immune response framework, existing analyses that have been limited to the traditional setting could substantially miss some of the most significant players and contributors. If, as suggested here, the vaccine-instigated immune response is to a significant proportion evoked by the EVs, then numerous analyses related to mRNA vaccines would require substantial revision. From a modeling, analysis, clinical, and environmental perspective, the prevailing efforts may be seen as barking up the wrong tree. Moreover, given that EV-immune activity can be disseminated without being easily attributable, this raises serious questions about clinical ramifications, their proper diagnosis and treatment, their misuse potential as well as unforeseen, and potentially irrevocable consequences across the biosphere.