The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) threatens global public health. The development of a vaccine is urgently needed for the prevention and control of COVID-19. Here, we report the pilot-scale production of an inactivated SARS-CoV-2 vaccine candidate (BBIBP-CorV) that induces high levels of neutralizing antibodies titers in mice, rats, guinea pigs, rabbits, and nonhuman primates (cynomolgus monkeys and rhesus macaques) to provide protection against SARS-CoV-2. Two-dose immunizations using 2 μg/dose of BBIBP-CorV provided highly efficient protection against SARS-CoV-2 intratracheal challenge in rhesus macaques, without detectable antibody-dependent enhancement of infection. In addition, BBIBP-CorV exhibits efficient productivity and good genetic stability for vaccine manufacture. These results support the further evaluation of BBIBP-CorV in a clinical trial.

由严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 引起的 2019 年冠状病毒病 (COVID-19) 大流行威胁着全球公共卫生。预防和控制 COVID-19 迫切需要开发疫苗。在此，我们报告了一种灭活 SARS-CoV-2 候选疫苗 (BBIBP-CorV) 的中试规模生产，该候选疫苗可在小鼠、大鼠、豚鼠、兔子和非人类灵长类动物（食蟹猴和恒河猴）中诱导高水平的中和抗体滴度猕猴）以提供针对 SARS-CoV-2 的保护。使用 2 μg/剂量的 BBIBP-CorV 进行两剂免疫可为恒河猴提供针对 SARS-CoV-2 气管内攻击的高效保护，且未检测到抗体依赖性感染增强。此外，BBIBP-CorV 在疫苗生产方面表现出高效的生产力和良好的遗传稳定性。这些结果支持在临床试验中进一步评估 BBIBP-CorV。