European Commission, Joint Research Centre (JRC), Ispra, Italy.
Laboratory of Molecular Microbiology and Biotechnology, Department of Medical Biotechnologies, University of Siena, 53100 Siena, Italy.
Int J Mol Sci. 2022 Aug 9;23(16):8838. doi: 10.3390/ijms23168838.
PEGylated lipids are one of the four constituents of lipid nanoparticle mRNA COVID-19 vaccines. Therefore, various concerns have been raised on the generation of anti-PEG antibodies and their potential role in inducing hypersensitivity reactions following vaccination or in reducing vaccine efficacy due to anti-carrier immunity. Here, we assess the prevalence of anti-PEG antibodies, in a cohort of vaccinated individuals, and give an overview of their time evolution after repeated vaccine administrations. Results indicate that, in our cohort, the presence of PEG in the formulation did not influence the level of anti-Spike antibodies generated upon vaccination and was not related to any reported, serious adverse effects. The time-course analysis of anti-PEG IgG showed no significant booster effect after each dose, whereas for IgM a significant increase in antibody levels was detected after the first and third dose. Data suggest that the presence of PEG in the formulation does not affect safety or efficacy of lipid-nanoparticle-based COVID-19 vaccines.
聚乙二醇化脂质是 mRNA COVID-19 疫苗的四种成分之一。因此，人们对产生抗聚乙二醇抗体及其在接种后引发过敏反应或通过抗载体免疫降低疫苗效力的潜在作用表示了各种关注。在这里，我们评估了接种疫苗个体中抗聚乙二醇抗体的流行率，并概述了它们在重复疫苗接种后的时间演变。结果表明，在我们的队列中，制剂中聚乙二醇的存在并不影响接种疫苗时产生的抗尖峰抗体的水平，也与任何报告的严重不良事件无关。抗聚乙二醇 IgG 的时间过程分析显示，每次接种后都没有明显的增强效应，而 IgM 的抗体水平在第一和第三剂后显著增加。数据表明，制剂中聚乙二醇的存在不会影响基于脂质纳米颗粒的 COVID-19 疫苗的安全性或效力。
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