{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,12]],"date-time":"2025-10-12T01:28:38Z","timestamp":1760232518871,"version":"build-2065373602"},"reference-count":37,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2022,11,10]],"date-time":"2022-11-10T00:00:00Z","timestamp":1668038400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Operational Programme from the budget of the Central Region of Portugal, within the European Social Fund (ESF) component","award":["CENTRO-04-3559-FSE-000162"],"award-info":[{"award-number":["CENTRO-04-3559-FSE-000162"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>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\u2019 data.<\/jats:p>","DOI":"10.3390\/vaccines10111896","type":"journal-article","created":{"date-parts":[[2022,11,10]],"date-time":"2022-11-10T19:17:34Z","timestamp":1668107854000},"page":"1896","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Early Real-World Data to Assess Benefits and Risks of COVID-19 Vaccines: A Systematic Review of Methods"],"prefix":"10.3390","volume":"10","author":[{"given":"Tatiane B.","family":"Ribeiro","sequence":"first","affiliation":[{"name":"Postgraduate Program of Epidemiology, Department of Epidemiology, School of Public Health, Universidade de S\u00e3o Paulo, S\u00e3o Paulo 01246-904, SP, Brazil"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0169-3788","authenticated-orcid":false,"given":"F\u00e1tima","family":"Roque","sequence":"additional","affiliation":[{"name":"Research Unit for Inland Development, Polytechnic of Guarda (UDI\/IPG), 6300-559 Guarda, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9766-9971","authenticated-orcid":false,"given":"Fidelia","family":"Ida","sequence":"additional","affiliation":[{"name":"CSL Behring, 1020 1st Ave, King of Prussia, PA 19406, USA"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2316-6770","authenticated-orcid":false,"given":"Ana I.","family":"Pl\u00e1cido","sequence":"additional","affiliation":[{"name":"Research Unit for Inland Development, Polytechnic of Guarda (UDI\/IPG), 6300-559 Guarda, Portugal"}]},{"given":"Mai","family":"Vu","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy, HUTECH University, Ho Chi Minh City 70000, Vietnam"},{"name":"School of Pharmacy, University of Eastern Finland, 70210 Kuopio, Finland"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2553-3159","authenticated-orcid":false,"given":"Jose J.","family":"Hern\u00e1ndez-Mu\u00f1oz","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, Irma Lerma Rangel College of Pharmacy, Texas A&M University, College Station, TX 77843-0000, USA"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0500-4049","authenticated-orcid":false,"given":"Maria Teresa","family":"Herdeiro","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences, iBiMED\u2013Institute of Biomedicine, Universidade de Aveiro, 3810-193 Aveiro, Portugal"}]}],"member":"1968","published-online":{"date-parts":[[2022,11,10]]},"reference":[{"key":"ref_1","first-page":"157","article-title":"WHO Declares COVID-19 a Pandemic","volume":"91","author":"Cucinotta","year":"2020","journal-title":"Acta Biomed."},{"key":"ref_2","unstructured":"US Food and Drug Administration (2021, November 01). 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