Existing and Emerging mRNA Vaccines and their Environmental Impact - a Transdisciplinary Assessment

Abstract

mRNA vaccines have played a momentous role during the COVID-19 pandemic and are now being developed for numerous other applications for humans, animals, and wildlife. Yet, 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 calls for a transdisciplinary approach, done 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, and (4) studies on mRNA-LNP platforms that implicate extracellular vesicles (EVs) as superior carriers. Thereby, I obtain the first extrapolation of 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.This analysis shows that the vaccine-derived bioactive material dispersed by EVs or impacted human microbiota is prone to exacerbate known risks in the existing context of genetic or chemical pollution, fostering pathogen evolution and dissemination in the open environment and driving widespread ecosystem disturbances. Additionally highlighting specific open questions, I anticipate this analysis to be the starting point 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, animal, and wildlife mRNA technologies. Regulatory measures are urgently needed to remediate potentially large-scale damage to public and ecosystem health as well as adverse societal, economic, and legal implications.