In the context of preliminary concerns with vaccine vectors, it may be also be constructive to discuss whether RNA vaccines would have qualities that obviate any apprehension for cellular transformation and a need for regulatory genotoxicity studies (1). Advances in the application of these vaccines are no less an emerging reality as evidenced by the successful mRNA vaccine production for COVID-19 which has progressed to Phase 3 human studies (2,3). Enthusiasm for RNA vaccines has been accompanied by the belief that genomic integration is not possible (4,5). With the uptake into the cytoplasm rather than nucleus, and with the presumed lack of ability for cytoplasmic RNA to be integrated without reverse transcription, others have continued to echo this feature of presumed safety (6,7). Hinz et al. pose this issue as ‘… not even a theoretical risk for insertional mutagenesis …’ (8).

中文翻译：

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RNA 疫苗是否不需要进行基因毒性研究？

在对疫苗载体的初步关注的背景下，讨论 RNA 疫苗是否具有消除对细胞转化的任何担忧和对调节性基因毒性研究的需要的特性也可能是建设性的 (1)。这些疫苗应用的进展同样是一个新兴的现实，成功的 COVID-19 mRNA 疫苗生产证明了这一点，该疫苗已进入 3 期人体研究 (2,3)。对 RNA 疫苗的热情伴随着一种信念，即基因组整合是不可能的 (4,5)。由于被吸收到细胞质而不是细胞核中，并且假定细胞质 RNA 在不进行逆转录的情况下缺乏整合能力，其他人继续回应这种假定的安全性特征 (6,7)。欣茨等人。 将此问题提出为“......甚至没有插入诱变的理论风险......”（8）。