Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA, 19104, USA.
Division of Public Health Sciences, Washington University School of Medicine in St. Louis, St. Louis, MO, USA.
Sci Rep. 2022 Jun 29;12(1):10946. doi: 10.1038/s41598-022-13809-7.
Severe adverse events (AEs) after COVID-19 vaccination are not well studied in randomized controlled trials (RCTs) due to rarity and short follow-up. To monitor the safety of COVID-19 vaccines ("Pfizer" vaccine dose 1 and 2, "Moderna" vaccine dose 1 and 2, and "Janssen" vaccine single dose) in the U.S., especially regarding severe AEs, we compare the relative rankings of these vaccines using both RCT and the Vaccine Adverse Event Reporting System (VAERS) data. The risks of local and systemic AEs were assessed from the three pivotal COVID-19 vaccine trials and also calculated in the VAERS cohort consisting of 559,717 reports between December 14, 2020 and September 17, 2021. AE rankings of the five vaccine groups calculated separately by RCT and VAERS were consistent, especially for systemic AEs. For severe AEs reported in VAERS, the reported risks of thrombosis and GBS after Janssen vaccine were highest. The reported risk of shingles after the first dose of Moderna vaccine was highest, followed by the second dose of the Moderna vaccine. The reported risk of myocarditis was higher after the second dose of Pfizer and Moderna vaccines. The reported risk of anaphylaxis was higher after the first dose of Pfizer vaccine. Limitations of this study are the inherent biases of the spontaneous reporting system data, and only including three pivotal RCTs and no comparison with other active vaccine safety surveillance systems.
由于罕见性和随访时间短，新冠疫苗接种后的严重不良事件（AE）在随机对照试验（RCT）中研究得并不充分。为了监测新冠疫苗在美国的安全性（“辉瑞”疫苗 1 剂和 2 剂、“莫德纳”疫苗 1 剂和 2 剂、“杨森”疫苗单剂），特别是严重 AE，我们比较了 RCT 和疫苗不良事件报告系统（VAERS）数据中这些疫苗的相对排名。通过三项关键新冠疫苗试验评估了局部和全身 AE 的风险，还计算了 2020 年 12 月 14 日至 2021 年 9 月 17 日期间由 559717 份报告组成的 VAERS 队列中的风险。由 RCT 和 VAERS 分别计算的五组疫苗的 AE 排名是一致的，特别是全身 AE。VAERS 报告的严重 AE 中，杨森疫苗接种后报告的血栓形成和吉兰-巴雷综合征风险最高。莫德纳疫苗首剂后报告的带状疱疹风险最高，其次是莫德纳疫苗第二剂。辉瑞和莫德纳疫苗第二剂后报告的心肌炎风险更高。辉瑞疫苗首剂后报告的过敏反应风险更高。本研究的局限性在于自发报告系统数据固有的偏倚，仅包括三项关键 RCT，且未与其他主动疫苗安全性监测系统进行比较。
