mRNA Vaccines as a Novel Class of Gene-Based Medical Intervention: Epistemic Responsibility and Informed Consent in Platform Medicine

The rapid development and deployment of mRNA vaccines against COVID-19 has widely been presented as a scientific success, often framed as a natural extension of established vaccination practices. This classificatory framing played a central role in enabling accelerated authorisation and large-scale use during a global health emergency. This article argues that, independent of empirical assessments of safety or effectiveness, mRNA vaccines constitute an epistemically novel class of gene-based medical intervention. Unlike conventional vaccines, which expose the immune system to antigens or antigen-producing pathogens, mRNA vaccines rely on the systemic delivery of exogenous genetic information, inducing human cells to transiently produce a target antigen through endogenous translational mechanisms. This represents a historically unprecedented form of large-scale mRNA transfection in humans. The article does not aim to evaluate clinical outcomes or population-level risk–benefit ratios. Instead, it examines the ethical implications of introducing a novel biomedical platform under an established semantic and regulatory category. Focusing on the relationship between technological novelty, epistemic uncertainty, and epistemic responsibility, it asks whether existing ethical frameworks for vaccination adequately capture the epistemic conditions under which authorisation, communication, and informed consent occurred. The central claim is that the ethical evaluation of mRNA vaccines cannot proceed without first acknowledging their epistemic novelty. Failure to do so risks obscuring responsibility for uncertainty management, misallocating epistemic burdens, and undermining the conditions for meaningful informed consent. The analysis is explicitly time-indexed and reconstructive, examining the epistemic context at the time of initial deployment rather than later empirical developments. This manuscript is a preprint of a work currently under review at Medicine, Health Care and Philosophy (Springer Nature). It has not undergone peer review. The present version is made publicly available to establish a timestamped record of the conceptual framework and to invite scholarly feedback. The content may differ from the final published version following peer review and editorial revision.