Antimicrobial Resistance Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.
Department of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
Sci Rep. 2021 Nov 2;11(1):21464. doi: 10.1038/s41598-021-00963-7.
The Sputnik V is a COVID- 19 vaccine developed by the Gamalia institute of epidemiology and microbiology and released on August 11, 2020. We provided independent evidence on side effects and immunogenicity following the administration of the Sputnik V COVID-19 in Iran. In this observational study, the healthcare workers who were vaccinated with the Sputnik V COVID-19 vaccine within February and April 2021 were evaluated. Among a total of 13,435 vaccinated healthcare workers, we received 3236 self-declaration reports of Sputnik V associated adverse events with the mean age 39.32 ± 10.19 years old which 38.8% were men and 61.2% were women. Totally 68.8% of females versus 66.2% of males reported side effects after receiving the first dose and 31.2% of females versus 33.8% of males reported side effects after the second dose of vaccine. The most common side effect was a pain in the injection site (56.9%), fatigue (50.9%), body pain (43.9%), headache (35.7%), fever (32.9%), joint pain (30.3%), chilling (29.8%) and drowsiness (20.3%). Side effects of the vaccine were significantly more frequent in females and younger individuals. Among a total of 238 participants, more than 90% after the first and second dose of vaccine had a detectable level of SARS-CoV-2 RBD antibody and SARS-CoV-2 neutralizing antibody. Although the overall rate of adverse effects was higher than the interim results from randomized controlled trials, our findings support the manufacturer's reports about the high humoral immunogenicity of vaccine against COVID-19.
卫星 V 是加马列亚流行病学和微生物学研究所研发的一种 COVID-19 疫苗，于 2020 年 8 月 11 日推出。我们提供了独立的关于卫星 V COVID-19 在伊朗接种后的副作用和免疫原性的数据。在这项观察性研究中，评估了 2021 年 2 月至 4 月期间接种卫星 V COVID-19 疫苗的医护人员。在总共 13435 名接种疫苗的医护人员中，我们收到了 3236 份关于卫星 V 相关不良事件的自我报告，平均年龄为 39.32±10.19 岁，其中 38.8%为男性，61.2%为女性。总共 68.8%的女性和 66.2%的男性在接种第一剂后报告了副作用，31.2%的女性和 33.8%的男性在接种第二剂后报告了副作用。最常见的副作用是注射部位疼痛（56.9%）、疲劳（50.9%）、身体疼痛（43.9%）、头痛（35.7%）、发烧（32.9%）、关节痛（30.3%）、发冷（29.8%）和困倦（20.3%）。女性和年轻个体的疫苗副作用更常见。在总共 238 名参与者中，超过 90%的人在接种第一和第二剂疫苗后，SARS-CoV-2 RBD 抗体和 SARS-CoV-2 中和抗体的水平可检测到。尽管总的不良事件发生率高于随机对照试验的中期结果，但我们的研究结果支持了制造商关于疫苗对 COVID-19 高体液免疫原性的报告。
