Development and Production of SARS-CoV2 Biologicals and Vaccines

冠状病毒疫苗和蛋白质试剂将在VPP开发。这些疫苗可以按照当前的良好制造规范(CGMP)通过用于人体临床试验的VCMP生产，并在健康的人类志愿者身上释放用于人体临床试验。这些疫苗可能会对贝塔冠状病毒和多种毒株/变种产生广泛的免疫力。如果这些试验在人体试验中证明了这些疫苗的安全性和免疫原性，可能会在更大规模的(第二阶段)试验中进行进一步的评估，这将需要更大规模的临床试验材料(CTM)的生产。正在开发的疫苗包括基于信使核糖核酸的疫苗。VPP还领导了与Afrigen Biologics and Vaccines的研究合作，重点是交流可用于制造RNA疫苗的科学专业知识，包括生产PDNA以支持Afrigens CoV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 mRNA-based vaccines. The VPP is also leading a research collaboration with Afrigen Biologics and Vaccines, focused on exchanging scientific expertise that may be used to make mRNA vaccines, including the production of pDNA in support of Afrigens CoV vaccine.