Evaluation of the Real-World Effectiveness of Vaccines against COVID-19 at a Local Level: Protocol for a Test-Negative Case–Control Study

Vaccines

Raquel Duarte¹  Ana Aguiar¹  Cátia Brazete¹  Marta Pinto²  Filipe Alves²  Lígia Sá³ 

[1] EPIUnit—Instituto de Saúde Pública, Universidade do Porto, 4050-600 Porto, Portugal;Unidade de Investigação Clínica da ARS Norte, 4000-477 Porto, Portugal;Unidade de Saúde Pública do Alto Minho, 4904-459 Viana do Castelo, Portugal;

关键词: COVID-19 vaccines;    effectiveness;    case–control studies;    district hospitals;   

DOI  :  10.3390/vaccines10050822

来源: DOAJ

【 摘 要 】

Vaccines against COVID-19 approved for use in the EU/EEA have been shown to be highly effective against wild-type SARS-CoV-2. However, their effectiveness against new variants may be reduced. This study aims to evaluate the effectiveness of vaccines against COVID-19 in the prevention of symptomatic and severe disease, during pre- and post-omicron phases. Individuals who sought treatment at the emergency department of a Portuguese hospital with COVID-19-like disease and were tested for SARS-CoV-2 are the subjects of the study. Patients who received a positive result are considered cases, while those with negative results are the controls. The test-negative case–control method is one of the study designs recommended by WHO to estimate the effectiveness of vaccines against COVID-19. The main advantage of this design is that it controls for the healthcare seeking bias, commonly present in traditional cohort and case–control designs. This study may have broad implications for understanding the real-world performance of the COVID-19 vaccines at the local level, which may play a key role in promoting adherence to vaccination. Moreover, this study may contribute to inform decisions regarding booster doses and variant-specific vaccine formulations leading to the control of this and future pandemics.

【 授权许可】

Unknown