Ribeiro Tatiane B, Roque Fátima, Ida Fidelia, Plácido Ana I, Vu Mai, Hernández-Muñoz Jose J, Herdeiro Maria Teresa
Postgraduate Program of Epidemiology, Department of Epidemiology, School of Public Health, Universidade de São Paulo, São Paulo 01246-904, SP, Brazil.
Research Unit for Inland Development, Polytechnic of Guarda (UDI/IPG), 6300-559 Guarda, Portugal.
Vaccines (Basel). 2022 Nov 10;10(11):1896. doi: 10.3390/vaccines10111896.
Since the authorization of the first COVID-19 vaccines in December 2020, multiple studies using real-world data (RWD) have been published to assess their effectiveness/safety profile. This systematic review aimed to characterize the methods and outcomes of studies using RWD for assessment of COVID-19 vaccines, four months after vaccine approval. MEDLINE and EMBASE were searched to identify published studies until 6 May 2021. Two independent researchers selected relevant publications and extracted data from included studies. The risk of bias was assessed using New-Castle Ottawa tools. After screening 1086 studies, 15 were included. Out of the 15 studies, 12 (80%) followed a cohort design, 8 (53%) were based on USA data, 7 (47%) assessed health care professionals, and 14 articles (93%) assessed the BNT162b2 vaccine. Data sources included institutional databases, electronic health records, and patient-generated data. The primary endpoint mainly described was SARS-CoV-2-infection. Hospitalization and mortality were assessed in 2 studies. For the comparability domain, six studies (40%) had a high risk of bias. A few months after the beginning of COVID-19 vaccination, Real-world Evidence (RWE) provided timely safety surveillance and comparative effectiveness with findings that showed similar findings to Randomized control trial (RCT). Most of the initiatives assessed BNT162b2 and were conducted in the USA and used healthcare workers' data.
自2020年12月首批新冠疫苗获批以来，已有多项利用真实世界数据（RWD）的研究发表，以评估其有效性/安全性。本系统评价旨在描述在疫苗获批四个月后，利用真实世界数据评估新冠疫苗的研究方法和结果。检索MEDLINE和EMBASE以识别截至2021年5月6日发表的研究。两名独立研究人员选择相关出版物并从纳入研究中提取数据。使用纽卡斯尔渥太华工具评估偏倚风险。在筛选了1086项研究后，纳入了15项。在这15项研究中，12项（80%）采用队列设计，8项（53%）基于美国数据，7项（47%）评估医护人员，14篇文章（93%）评估BNT162b2疫苗。数据来源包括机构数据库、电子健康记录和患者生成的数据。主要描述的主要终点是SARS-CoV-2感染。两项研究评估了住院率和死亡率。在可比性领域，六项研究（40%）存在高偏倚风险。在新冠疫苗接种开始几个月后，真实世界证据（RWE）提供了及时的安全性监测和比较有效性，其结果与随机对照试验（RCT）相似。大多数研究评估了BNT162b2，在美国进行，并使用了医护人员的数据。
