Adjuvant Activity and Toxicological Risks of Lipid Nanoparticles Contained in the COVID‑19 “mRNA Vaccines”

International Journal of Vaccine Theory, Practice, and Research Pub Date : 2024-03-02 DOI:10.56098/z1ydjm29

Gabriele Segalla

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Abstract

The LNPs reportedly used as the platform by Pfizer/BioNTech for its SARS-CoV-2 “mRNA vaccines” allegedly consist of a mixture of phospholipids, cholesterol, PEGylated lipids, and an ionizable cationic lipid. This study reviews some of the main toxicological risks and immunostimulatory properties of such nanomaterials, with particular attention to the ionizable LNPs and their adjuvant properties, inflammatory responses, stimulation of immune cells, and formation of ROS inside transfected cells. The decision not to carry out safety pharmacology, carcinogenicity, and genotoxicity tests on these nanomaterials appears unjustifiable and in contradiction with the international policies provided for novel adjuvants. Important gaps are highlighted on the activities by the relevant regulatory bodies, related to the scientific evaluation, risk management, and pharmacovigilance for new medicinal products in the EU. Given the findings discussed here, it is strongly urged that the mRNA-LNP-based “vaccines” and their boosters should be removed from the worldwide market because of unacceptable and potentially fatal safety risks.

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COVID-19 "mRNA疫苗 "所含脂质纳米粒子的佐剂活性和毒理学风险

据报道，Pfizer/BioNTech 公司用作其 SARS-CoV-2 "mRNA 疫苗 "平台的 LNPs 据称由磷脂、胆固醇、PEG 化脂类和可离子化阳离子脂类混合物组成。本研究回顾了此类纳米材料的一些主要毒理学风险和免疫刺激特性，尤其关注可离子化的 LNPs 及其佐剂特性、炎症反应、免疫细胞刺激和转染细胞内 ROS 的形成。不对这些纳米材料进行安全药理学、致癌性和遗传毒性测试的决定似乎是不合理的，也与国际上针对新型佐剂的政策相悖。本文强调了相关监管机构在欧盟新药的科学评估、风险管理和药物警戒方面存在的重要差距。鉴于本文讨论的结果，强烈呼吁基于 mRNA-LNP 的 "疫苗 "及其增效剂应从全球市场上撤下，因为它们存在不可接受的、可能致命的安全风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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International Journal of Vaccine Theory, Practice, and Research

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