Sa Soonok, Lee Chae Won, Shim Sung Ryul, Yoo Hyounggyoon, Choi Jinwha, Kim Ju Hee, Lee Kiwon, Hong Myunghee, Han Hyun Wook
Department of Biomedical Informatics, CHA University School of Medicine, CHA University, Seongnam 13488, Korea.
Institute of Basic Medical Sciences, School of Medicine, CHA University, Seongnam 13488, Korea.
Vaccines (Basel). 2022 Feb 17;10(2):320. doi: 10.3390/vaccines10020320.
Two mRNA COVID-19 vaccines (mRNA-1273, Moderna; and BNT162b2, Pfizer-BioNTech) and one viral vector vaccine (JNJ-78436735, Janssen/Johnson and Johnson) are authorized in the US to hinder COVID-19 infections. We analyzed severe and common adverse events in response to COVID-19 vaccines using real-world, Vaccine Adverse Effect Reporting System (VAERS) data. From 14 December 2020 to 30 September 2021, 481,172 (50.7 ± 17.5 years, males 27.89%, 12.35 per 100,000 people) individuals reported adverse events (AEs). The median time to severe AEs was 2 days after injection. The risk of severe AEs following the one viral vector vaccine (OR = 1.044, 95% CI = 1.005-1.086) was significantly higher than that after the two mRNA vaccines, and the risk among males (OR = 1.374, 95% CI = 1.342-1.406) was higher than among females, except for anaphylaxis. For common AEs, however, the risk to males (OR = 0.621, 95% CI = 0.612-0.63) was lower than to females. In conclusion, we provided medical insight and clinical guidance about vaccine types by characterizing AEs using real-world data. In particular, COVID-19 mRNA vaccines are safer than viral vector vaccines with regard to coagulation disorders, whereas inflammation-related AEs are lower in the viral vaccine. The risk-benefit ratio of vaccines should be carefully considered, and close monitoring and management of severe AEs is needed.
两种mRNA新冠疫苗（mRNA-1273，Moderna公司；以及BNT162b2，辉瑞-生物科技公司）和一种病毒载体疫苗（JNJ-78436735，杨森/强生公司）在美国被批准用于预防新冠病毒感染。我们使用真实世界的疫苗不良反应报告系统（VAERS）数据，分析了接种新冠疫苗后的严重和常见不良事件。在2020年12月14日至2021年9月30日期间，有481,172人（年龄50.7±17.5岁，男性占27.89%，每10万人中有12.35人）报告了不良事件（AE）。严重不良事件发生的中位时间为注射后2天。接种一种病毒载体疫苗后发生严重不良事件的风险（OR = 1.044，95%CI = 1.005 - 1.086）显著高于接种两种mRNA疫苗后的风险，男性发生严重不良事件的风险（OR = 1.374，95%CI = 1.342 - 1.406）高于女性，但过敏反应除外。然而，对于常见不良事件，男性发生的风险（OR = 0.621，95%CI = 0.612 - 0.63）低于女性。总之，我们通过使用真实世界数据对不良事件进行特征分析，提供了有关疫苗类型的医学见解和临床指导。特别是，在凝血障碍方面，新冠mRNA疫苗比病毒载体疫苗更安全，而与炎症相关的不良事件在病毒载体疫苗中发生率较低。应仔细考虑疫苗的风险效益比，并且需要对严重不良事件进行密切监测和管理。
