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评估 COVID-19 不同疫苗方案在 18 个月随访研究中的长期不良事件。

Assessment of long-term adverse events regarding different COVID-19 vaccine regimens within an 18-month follow-up study.

机构信息

Clinical Research Department, Pasteur Institute of Iran, Tehran 1316943551, Iran.

IPI Directorate, Pasteur Institute of Iran, Tehran 1316943551, Iran.

出版信息

Pathog Dis. 2023 Jan 17;81. doi: 10.1093/femspd/ftad010.

Abstract

Early reports on coronavirus disease 2019 (COVID-19) vaccines presented the short-term adverse events (AEs). This follow-up study investigated a standard regimen based on protein subunit vaccines, PastoCovac and PastoCovac Plus, and the combinational vaccine regimens including AstraZeneca/PastoCovac Plus and Sinopharm/PastoCovac Plus. The participants were followed up to 6 months post the booster shot. All the AEs were collected through in-depth interviews using a valid researcher-made questionnaire and were evaluated regarding the association with the vaccines. Of the 509 individuals, 6.2% of the combinational vaccine participants had late AEs, of whom 3.3% suffered from cutaneous manifestations, followed by 1.1% arthralgia complaints, 1.1% with neurologic disorders, 0.3% ocular problems and 0.3% metabolic complications, with no significant difference between the vaccine regimens. For the standard regimen, 2% of the individuals experienced late AEs as (1%), neurological disorders (0.3%), metabolic problems (0.3%) and involvement of joints (0.3%). Notably, 75% of the AEs were persistent up to the end of the study. A low number of late AEs were captured in 18 months as 12 improbable, 5 unclassifiable, 4 possible and 3 probable associated AEs with the vaccine regimens. The benefits of COVID-19 vaccination far exceed the potential risks and late AEs seem to be uncommon.

摘要

关于 2019 年冠状病毒病(COVID-19)疫苗的早期报告介绍了短期不良反应(AE)。本随访研究调查了基于蛋白亚单位疫苗 PastoCovac 和 PastoCovac Plus 的标准方案,以及包括阿斯利康/PastoCovac Plus 和国药/PastoCovac Plus 在内的联合疫苗方案。参与者在加强针接种后 6 个月进行随访。所有 AE 均通过使用有效研究者自制问卷进行深入访谈收集,并根据与疫苗的关联性进行评估。在 509 名参与者中,联合疫苗组有 6.2%的人出现迟发性 AE,其中 3.3%出现皮肤表现,其次是 1.1%的关节痛投诉,1.1%的神经紊乱,0.3%的眼部问题和 0.3%的代谢并发症,疫苗方案之间无显著差异。对于标准方案,有 2%的个体出现迟发性 AE(1%),神经紊乱(0.3%),代谢问题(0.3%)和关节受累(0.3%)。值得注意的是,75%的 AE 在研究结束时仍持续存在。在 18 个月时,仅捕获到 12 例不太可能、5 例无法分类、4 例可能和 3 例与疫苗方案相关的迟发性 AE,数量较少。COVID-19 疫苗接种的益处远远超过潜在风险,迟发性 AE 似乎并不常见。

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