Preventive Medicine and Public Health Research Center, Psychosocial Health Research Institute, Department of Community and Family Medicine, School of Medicine, Iran University of Medical Sciences, Shahid Hemmat Highway, P.O Box: 14665-354, Tehran, 1449614535, Iran.
Mazandaran University of medical Science, Sari, Iran, Mazandaran University of medical Science, Sari, Iran, Mazandaran, Sari, Iran.
BMC Infect Dis. 2022 May 18;22(1):476. doi: 10.1186/s12879-022-07411-5.
Vaccination is a key intervention to prevent COVID-19. Many vaccines are administered globally, yet there is not much evidence regarding their safety and adverse effects. Iran also faces this challenge, especially as data regarding the Sputnik V vaccine is sparse. Therefore, the aim of this study is to determine the adverse effects of the most commonly used vaccines in Iran.
Using a retrospective cohort study design, 6600 subjects aged 18 years or older who had received two doses of any of the three COVID-19 vaccines (Sinopharm, AstraZeneca, and Sputnik V) were selected using a random sampling method between March and August 2021. Subjects were asked about any adverse effects of the vaccines by trained interviewers via telephone interview. Vaccine-related adverse effects in individuals during the first 72 h and subsequently following both doses of the vaccines were determined. The demographic variables, type of administered vaccine, adverse effects, and history of the previous infection with COVID-19 were collected. Descriptive statistics (mean, standard deviation) and analytical statistics (Chi-squared and Wilcoxon tests) were performed at a 95% significance level using STATA software version 15 (STATA Corp, College Station, TX, USA).
From 6600 participants, 4775 responded (response rate = 72.3%). Of the participants, 1460 (30.6%) received the AstraZeneca vaccine, 1564 (32.8%) received the Sinopharm vaccine and 1751 (36.7%) received the Sputnik V vaccine. 2653 participants (55.56%) reported adverse effects after the first dose and 1704 (35.7%) after the second dose. Sputnik V caused the most adverse effects with 1449 (82.7%) vaccine recipients reporting symptoms after the first or second dose, compared with 1030 (70.5%) for AstraZeneca and only 585 (37.4%) for the Sinopharm vaccine. The most common adverse effects after the first dose were fatigue (28.37%), chill/fever (26.86%), and skeletal pain (22.38%). These three adverse effects were the same for the second dose, although their prevalence was lower.
In this study, we demonstrate that the Sputnik V vaccine has the highest rate of adverse effects, followed by the AstraZeneca and Sinopharm vaccines. COVID-19 vaccines used in Iran are safe and there were no reports of serious adverse effects.
接种疫苗是预防 COVID-19 的关键干预措施。许多疫苗在全球范围内使用,但关于它们的安全性和不良反应的证据并不多。伊朗也面临着这一挑战,尤其是关于 Sputnik V 疫苗的数据很少。因此,本研究的目的是确定伊朗最常用疫苗的不良反应。
采用回顾性队列研究设计,2021 年 3 月至 8 月期间,采用随机抽样法从年龄在 18 岁及以上、接种过两剂任何三种 COVID-19 疫苗(国药、阿斯利康和 Sputnik V)的 6600 名受试者中选取 6600 名受试者。通过电话访谈,由经过培训的访谈员询问受试者疫苗的任何不良反应。确定疫苗接种后 72 小时内和接种后两剂疫苗后个体的疫苗相关不良反应。收集人口统计学变量、接种疫苗类型、不良反应和以前感染 COVID-19 的病史。使用 STATA 软件版本 15(STATA 公司,德克萨斯州立大学学院站)在 95%置信水平下进行描述性统计(均值、标准差)和分析性统计(卡方和 Wilcoxon 检验)。
在 6600 名参与者中,有 4775 名(应答率为 72.3%)作出了回应。在参与者中,1460 名(30.6%)接种了阿斯利康疫苗,1564 名(32.8%)接种了国药疫苗,1751 名(36.7%)接种了 Sputnik V 疫苗。2653 名参与者(55.56%)在第一剂后报告了不良反应,1704 名(35.7%)在第二剂后报告了不良反应。Sputnik V 引起的不良反应最多,1449 名(82.7%)疫苗接种者在第一或第二剂后出现症状,阿斯利康为 1030 名(70.5%),国药仅为 585 名(37.4%)。第一剂后最常见的不良反应是疲劳(28.37%)、寒战/发热(26.86%)和骨骼疼痛(22.38%)。这三种不良反应在第二剂后也是相同的,尽管它们的发生率较低。
在这项研究中,我们证明了 Sputnik V 疫苗的不良反应发生率最高,其次是阿斯利康和国药疫苗。伊朗使用的 COVID-19 疫苗是安全的,没有报告严重不良反应。