Editorial
This issue features the third entry in a growing category of peer-reviewed scholarship in Science, Public Health Policy & the Law: the Policy Critique. This article type was created to provide a dedicated forum for rigorous, well-documented challenges to public health policy decisions, grounded in law, science, and ethics.
Policy Critiques are not op-eds. They are structured analyses that question the reasoning, evidence base, or procedural integrity of enacted or proposed public health measures. Their purpose is to bring forward dissenting but methodologically sound viewpoints, not to reach consensus—but to promote a culture in which policy decisions can be examined, debated, and improved through open, critical inquiry.
In this issue, Ueda et al. present a detailed review of the regulatory framework and safety oversight surrounding the approval and continued use of COVID-19 genetic vaccines in Japan. In their thorough and detailed and now peer-reviewed critique, the authors draw upon statutory language from the Pharmaceuticals and Medical Devices Act (PMD Act), post-marketing surveillance records, and publicly available epidemiological and molecular data. They argue that the legal and scientific conditions now warrant revocation of approval and market withdrawal of these products.
The journal does not take a position on the policy conclusions of this or any Policy Critique. Instead, we emphasize that papers like this are part of the ongoing process by which science-based policymaking is stress-tested, refined, and ultimately strengthened. Especially in areas where public confidence is at stake, space must be made for minority or non-aligned views to be expressed, so long as they meet standards of evidence, logic, and relevance.
We encourage our readers—particularly those involved in policy, regulation, or clinical decision-making—to engage with Policy Critiques in that spirit: as contributions to a broader scientific conversation, not end points. Authors with alternative interpretations or complementary analyses are invited to submit responses or independent critiques.
We thank Ueda et al. for their detailed contribution, and we look forward to continued use of the Policy Critique format as a mechanism for bringing rigorously developed dissent into the public record—where it belongs.
Ueda J, Gibo M, Kikuchi T, Hirai Y, Miyokawa M, Shima I et al. Regulatory and Safety Assessment of COVID-19 mRNA-LNP Genetic Vaccines in Japan: Evidence for Revocation of Approval and Market Withdrawal. Science, Public Health Policy and the Law. 2025 Aug 26; v8.2019-2025























