Department of Oncology, Xiangya Hospital, Central South University, Changsha, Hunan 410008, China; Key Laboratory for Molecular Radiation Oncology of Hunan Province, Xiangya Hospital, Central South University, Changsha, Hunan 410008, China.
Department of Life Science, McMaster University, Hamilton, ON L8S 4L8, Canada.
Mol Ther. 2021 Sep 1;29(9):2794-2805. doi: 10.1016/j.ymthe.2021.08.001. Epub 2021 Aug 6.
The numbers of cases and deaths from coronavirus disease 2019 (COVID-19) are continuously increasing. Many people are concerned about the efficacy and safety of the COVID-19 vaccines. We performed a comprehensive analysis of the published trials of COVID-19 vaccines and the real-world data from the Vaccine Adverse Event Reporting System. Globally, our research found that the efficacy of all vaccines exceeded 70%, and RNA-based vaccines had the highest efficacy of 94.29%; moreover, Black or African American people, young people, and males may experience greater vaccine efficacy. The spectrum of vaccine-related adverse drug reactions (ADRs) is extremely broad, and the most frequent ADRs are pain, fatigue, and headache. Most ADRs are tolerable and are mainly grade 1 or 2 in severity. Some severe ADRs have been identified (thromboembolic events, 21-75 cases per million doses; myocarditis/pericarditis, 2-3 cases per million doses). In summary, vaccines are a powerful tool that can be used to control the COVID-19 pandemic, with high efficacy and tolerable ADRs. In addition, the spectrum of ADRs associated with the vaccines is broad, and most of the reactions appear within a week, although some may be delayed. Therefore, ADRs after vaccination need to be identified and addressed in a timely manner.
新型冠状病毒肺炎(COVID-19)的病例和死亡人数持续增加。许多人担心 COVID-19 疫苗的疗效和安全性。我们对已发表的 COVID-19 疫苗试验和疫苗不良事件报告系统的真实世界数据进行了全面分析。在全球范围内,我们的研究发现,所有疫苗的有效性均超过 70%,基于 RNA 的疫苗有效性最高,达 94.29%;此外,黑种人或非裔美国人、年轻人和男性可能会经历更高的疫苗疗效。疫苗相关不良反应(ADR)的谱极为广泛,最常见的 ADR 是疼痛、疲劳和头痛。大多数 ADR 是可耐受的,主要为 1 级或 2 级严重程度。已经确定了一些严重的 ADR(血栓栓塞事件,每百万剂 21-75 例;心肌炎/心包炎,每百万剂 2-3 例)。总之,疫苗是控制 COVID-19 大流行的有力工具,具有高疗效和可耐受的 ADR。此外,疫苗相关的 ADR 谱很广,大多数反应出现在一周内,尽管有些可能会延迟。因此,需要及时识别和处理接种疫苗后的 ADR。