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Utilize este identificador para referenciar este registo: http://hdl.handle.net/10314/7060

Título: Early Real-World Data to Assess Benefits and Risks of COVID-19 Vaccines: A Systematic Review of Methods
Autores: Ribeiro, Tatiane
Roque, Fátima
Ida, Fidelia
Plácido, Ana
Vu, Mai
Hernández-Muñoz, José
Herdeiro, Maria
Palavras Chave: COVID-19
real-world data
Data: 10-Nov-2022
Resumo: 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.
URI: http://hdl.handle.net/10314/7060
ISSN: 36366404
Aparece nas Colecções:Artigos em Revista Internacional (ESS)

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