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Abstract：
A novel coronavirus (CoV), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in late 2019 in Wuhan, China and has since spread as a global pandemic. Safe and effective vaccines are thus urgently needed to reduce the significant morbidity and mortality of Coronavirus Disease 2019 (COVID-19) disease and ease the major economic impact. There has been an unprecedented rapid response by vaccine developers with now over one hundred vaccine candidates in development and at least six having reached clinical trials. However, a major challenge during rapid development is to avoid safety issues both by thoughtful vaccine design and by thorough evaluation in a timely manner. A syndrome of \"disease enhancement\" has been reported in the past for a few viral vaccines where those immunized suffered increased severity or death when they later encountered the virus or were found to have an increased frequency of infection. Animal models allowed scientists to determine the underlying mechanism for the former in the case of Respiratory syncytial virus (RSV) vaccine and have been utilized to design and screen new RSV vaccine candidates. Because some Middle East respiratory syndrome (MERS) and SARS-CoV-1 vaccines have shown evidence of disease enhancement in some animal models, this is a particular concern for SARS-CoV-2 vaccines. To address this challenge, the Coalition for Epidemic Preparedness Innovations (CEPI) and the Brighton Collaboration (BC) Safety Platform for Emergency vACcines (SPEAC) convened a scientific working meeting on March 12 and 13, 2020 of experts in the field of vaccine immunology and coronaviruses to consider what vaccine designs could reduce safety concerns and how animal models and immunological assessments in early clinical trials can help to assess the risk. This report summarizes the evidence presented and provides considerations for safety assessment of COVID-19 vaccine candidates in accelerated vaccine development.
摘要：
一种新型冠状病毒（CoV），严重急性呼吸道综合征冠状病毒2（SARS-CoV-2），2019年底在武汉出现，中国，此后作为全球大流行传播。因此，迫切需要安全有效的疫苗来降低2019年冠状病毒病(COVID-19)的显著发病率和死亡率，并缓解主要的经济影响。疫苗开发商做出了前所未有的快速反应，目前有100多种候选疫苗正在开发中，至少有6种已经进入临床试验。然而,在快速开发过程中，一个主要挑战是通过深思熟虑的疫苗设计和及时的全面评估来避免安全问题。过去曾报道过一些病毒疫苗的“疾病增强”综合征，这些疫苗接种的疫苗后来遇到病毒或发现感染频率增加时，严重程度增加或死亡。动物模型使科学家能够确定前者在呼吸道合胞病毒（RSV）疫苗的情况下的潜在机制，并已用于设计和筛选新的RSV疫苗候选物。因为一些中东呼吸综合征（MERS）和SARS-CoV-1疫苗在一些动物模型中显示出疾病增强的证据，这是SARS-CoV-2疫苗特别关注的问题。为了应对这一挑战，防疫创新联盟(CEPI)和布莱顿合作组织(BC)应急疫苗安全平台(SPEAC)于2020年3月12日和13日召开了疫苗免疫学和冠状病毒领域的专家科学工作会议,以考虑哪些疫苗设计可以减少安全性问题,以及早期临床试验中的动物模型和免疫学评估如何帮助评估风险.本报告总结了所提供的证据，并提供了在加速疫苗开发中对COVID-19候选疫苗进行安全性评估的注意事项。
