在18个月的随访研究中评估不同COVID-19疫苗方案的长期不良事件

IF 2.7 4区 医学 Q3 IMMUNOLOGY Pathogens and disease Pub Date : 2023-01-17 DOI:10.1093/femspd/ftad010
Mona Sadat Larijani, Rahim Sorouri, Sana Eybpoosh, Delaram Doroud, Ladan Moradi, Mozhgan Ahmadinezhad, Anahita Bavand, Fatemeh Ashrafian, Parinaz Tajmehrabi Namini, Mahsan Zali, Amitis Ramezani
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引用次数: 4

摘要

关于2019冠状病毒病(COVID-19)疫苗的早期报告显示了短期不良事件(ae)。该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。参与者在加强注射后随访了6个月。所有不良反应都是通过深度访谈收集的,使用有效的研究人员制作的问卷,并就其与疫苗的关系进行评估。在509名个体中,6.2%的联合疫苗参与者出现晚期ae,其中3.3%出现皮肤症状,1.1%出现关节痛,1.1%出现神经系统疾病,0.3%出现眼部问题,0.3%出现代谢并发症,疫苗方案之间无显著差异。对于标准方案,2%的个体经历晚期ae(1%),神经系统疾病(0.3%),代谢问题(0.3%)和关节受累(0.3%)。值得注意的是,75%的不良反应一直持续到研究结束。在18个月内捕获的晚期ae数量较少,其中12例不可能发生,5例无法分类,4例可能发生,3例可能与疫苗方案相关。COVID-19疫苗接种的益处远远超过潜在风险,晚期ae似乎并不常见。
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Assessment of long-term adverse events regarding different COVID-19 vaccine regimens within an 18-month follow-up study.

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.

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来源期刊
Pathogens and disease
Pathogens and disease IMMUNOLOGY-INFECTIOUS DISEASES
CiteScore
7.40
自引率
3.00%
发文量
44
期刊介绍: Pathogens and Disease publishes outstanding primary research on hypothesis- and discovery-driven studies on pathogens, host-pathogen interactions, host response to infection and their molecular and cellular correlates. It covers all pathogens – eukaryotes, prokaryotes, and viruses – and includes zoonotic pathogens and experimental translational applications.
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