The rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has elicited an equally rapid response aiming to develop a COVID-19 vaccine. These efforts are encouraging; however, comprehensive efficacy and safety evaluations are essential in the development of a vaccine, and we can learn from previous vaccine development campaigns. In this Perspective, we summarize examples of vaccine-associated disease enhancement in the history of developing vaccines against respiratory syncytial virus, dengue virus, SARS-CoV and Middle East respiratory syndrome coronavirus, which highlight the importance of a robust safety and efficacy profile, and present recommendations for preclinical and clinical evaluation of COVID-19 vaccine candidates as well as for vaccine design and optimization.

严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 的迅速传播引发了同样快速的反应，旨在开发 COVID-19 疫苗。这些努力令人鼓舞；然而，全面的功效和安全性评估对于疫苗的开发至关重要，我们可以从以往的疫苗开发活动中学习。在本视角中，我们总结了呼吸道合胞病毒、登革热病毒、SARS-CoV和中东呼吸综合征冠状病毒疫苗开发史上与疫苗相关疾病增强的例子，这些例子强调了稳健的安全性和有效性特征的重要性，以及提出有关 COVID-19 候选疫苗的临床前和临床评估以及疫苗设计和优化的建议。