Development and Production of SARS-CoV2 Biologicals and Vaccines

VPP将开发冠状病毒疫苗和蛋白质试剂。疫苗可通过VCMP按照现行药品生产质量管理规范（cGMP）生产用于人体临床试验，并放行用于健康人类志愿者的人体临床试验。这些疫苗可赋予对β-冠状病毒和多种毒株/变体的广泛免疫力。如果这些试验证明了这些疫苗在人体试验中的安全性和免疫原性，则可能在更大规模（2期）试验中进行进一步评价，这将需要以更大规模生产临床试验材料（CTM）。正在开发的疫苗包括基于纳米颗粒的疫苗和基于VLP的疫苗。

Coronavirus vaccines and protein reagents will be developed at the VPP. The vaccines may be manufactured through the VCMP for human clinical trials in compliance with current Good Manufacturing Practices (cGMP) and released for use in human clinical trials in healthy human volunteers. These vaccines may confer broad immunity across the beta-coronaviruses and against multiple strains / variants. If these trials demonstrate safety and immunogenicity of these vaccines in human trials, further evaluation may take place in larger (Phase 2) trials which will necessitate production of the clinical trial materials (CTM) at larger scale. Vaccines under development include nanoparticle-based vaccines VLP-based vaccines.