Just published in Environmental Sciences Europe: "Existing and emerging mRNA vaccines and their environmental impact: a transdisciplinary assessment"

SpringerLink for free access

This morning, I was greeted by the following email by SPRINGER NATURE:

Environmental Sciences Europe is a peer-reviewed open-access journal published under the brand SpringerOpen. Please view, download, and share the article! It is open access and can be freely accessed.

This new publication extends my previous work (my preprint – further discussed in my substack posts on March 04, 2024, March 15, 2024, March 29, 2024, April 03, 2024 ). It took some time to get it through peer review. However, I do have to emphasize the process was fair and diligent. I would like to thank the reviewers and editors for their important feedback! This forced me once again to think it all through and to highlight the relevance, definiteness, novelty, and, as I believe, urgency, of the issues that I am raising.

The starting point of this publication was several critical observations, including

• Issues of the lipid nanoparticles of the mRNA-LNP platforms.

• The role of EVs as carriers of synthetic genetic material.

• Pre-pandemic work on this.

• How the work of Bansal et al., who first demonstrated the seemingly prolonged presence of circulating exosomes containing mRNA “vaccine”-derived spike protein but later backpedaled their own findings, seems to be a replication of this prior knowledge.

• The shedding of mRNA vaccines to susceptible individuals and into the open environment – it means the uncontrolled spreading of biologically active material.

• Lack of studies of the environmental risk of existing and emerging mRNA platforms.

• Evidence that compounds of mRNA “vaccines” may survive digestion and be biologically active in consuming humans or animals.

In the article, I further scoped and reviewed

• Recent related literature.

• Previous literature that is highly relevant in this context, but which seems to have been overlooked.

• The importance of regulation, or lack thereof.

• How the gaps in regulation and study are shaped by nomenclature, emphasizing the gene-therapy nature of the mRNA “vaccines.”

For a short synopsis of the article, please note the abstract:

Abstract

mRNA vaccines have played a massive role during the COVID-19 pandemic and are now being developed for numerous other human and animal applications. Nevertheless, their potential ramifications on the environment lack scrutiny and regulation. On 14 July 2020, the EU decided to temporarily exclude the clinical trials with COVID-19 vaccines from prior environmental risk assessment. Even though billions of doses have been administered and large-scale agricultural and wildlife RNA applications are fast-tracked, there is no knowledge of their environmental impact via the dispersion of vaccine-derived material or their wastage. This knowledge gap is targeted here via a critical assessment of (1) the pharmacokinetic properties of these products; (2) their impact on the human microbiota; (3) novel risk factors exemplified by the human gut bacterium Escherichia coli resulting in pathogen evolution in the guts of wild animals, (4) findings on mRNA-LNP platforms that implicate extracellular vesicles (EVs) as superior carriers, and (5) potentials of exogenous regulatory RNAs. This analysis results in the first extrapolation of (a) the magnitude and likelihood of environmental risk as characterized by the FDA in 2015 for products that facilitate their action by transcription and/or translation of transferred genetic material or related processes, and (b) additional risks facilitated by the horizontal transfer of exogenous short RNAs. The arguments provided here establish the rationale for vaccine-derived bioactive material dispersed by EVs, impacted microbiota, and other exposed organisms to foster pathogen evolution, cross-species transfer of biological function, and driving widespread ecosystem disturbances. Evidence is emerging that vaccine-derived molecules, when ingested, could survive digestion and mediate gene expression regulation, host–parasite defense, immunity, and other responses in the consuming animals. Highlighting further unresolved questions, the comprehensive assessment provided here calls for open dialogue and more in-depth studies to get a clear picture in the EU and globally to most effectively gauge the environmental impact of existing and emerging human, livestock, and wildlife mRNA technologies or their potential as biological weapons or for other forms of misuse. Regulatory measures are urgently needed to mitigate potentially large-scale damage to public and ecosystem health as well as adverse societal, economic, and legal implications.

This article is the first that raises concerns about the environmental impact of the mRNA platforms. These technologies have spurred enormous excitement and hope in the resolution of other public health challenges and others, and numerous modifications and novel applications of this technology are in the works. Many of them are under accelerated approval because of the prevailing view that these are “just vaccines.”

Regardless of what people may think of them as “COVID-19 vaccines,” in terms of their environmental impact (open air but also direct contacts), their nature as drugs and gene therapy ought to be considered, and openly and rigorously scrutinized.

In light of plans to monumentally increase the application and scale of mRNA technologies to livestock, fish, and wild animals, via circulatory RNAs, self-amplifying, self-spreading or other novel platforms, and administration routes such as via food/feed or aerosolized, the risks and concerns described here call for open discussion, in-depth studies, and urgent regulatory measures to prevent potentially irreversible large-scale and far-reaching ramifications.

Considering the vast knowledge gaps and the potential consequences on the entire biosphere, it is imperative to separate the discussion of the environmental implications from whatever one may believe they did or did not do in the COVID-19 era. I hope the article will serve as a starting point for unbiased and insightful discussions.

The article is freely available online here https://doi.org/10.1186/s12302-024-00966-x or as a PDF here https://link.springer.com/content/pdf/10.1186/s12302-024-00966-x.pdf

For quick viewing and sharing a full-access text of the article, Springer Nature made the following stable, shortened URL available: https://rdcu.be/dQCjT 

Thank you for reading, sharing, and inviting others for constructive and open discussions!