Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA; Meta-Research Innovation Center Berlin (METRIC-B), Berlin Institute of Health, Berlin, Germany.
Department of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA, USA; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA.
J Clin Epidemiol. 2021 Oct;138:199-202. doi: 10.1016/j.jclinepi.2021.05.014. Epub 2021 May 25.
Vaccines are vital to control the Coronavirus disease 2019 (COVID-19) pandemic, but the pressure to quickly move from research to implementation in the context of a pandemic crisis raises concerns about benefits and harms, vaccine acceptance and fair access. Here we present a strategy for the COVID-19 vaccination rollout which can be rapidly embedded and would offer direct real-world evidence of vaccines on a large scale to generate otherwise unobtainable knowledge on the safety and perhaps efficacy of COVID-19 vaccines. Such strategic rollouts leveraging randomization can provide important evidence, for COVID-19 and in future occasions, for vaccines and beyond.
疫苗对于控制 2019 年冠状病毒病（COVID-19）大流行至关重要，但在大流行危机背景下，从研究迅速转向实施的压力引发了对疫苗的益处和危害、疫苗接种接受度和公平获取的关注。在这里，我们提出了一种 COVID-19 疫苗接种策略，该策略可以迅速实施，并将大规模提供 COVID-19 疫苗的直接真实世界证据，从而产生关于 COVID-19 疫苗安全性甚至有效性的其他无法获得的知识。这种利用随机化的策略性推出可以为 COVID-19 以及未来的疫苗和其他情况提供重要证据。
