Moderna的新冠病毒候选疫苗mRNA-1273,获得FDA批准进行II期临床研究

2020-05-08 MedSci原创 MedSci原创

Moderna公司宣布,FDA已经批准其实验性COVID-19疫苗mRNA-1273开展II期临床研究。

Moderna公司宣布,FDA已经批准其实验性COVID-19疫苗mRNA-1273开展II期临床研究。该疫苗将会在600名参与者中进行测试,并正在敲定于今年夏初开始III期临床试验。首席执行官Stéphane Bancel表示,该公司"目前正在准备进行其生物制剂许可证申请,最早将于2021年获得批准。"

图片来源:Shutterstock

Stéphane补充说,Moderna"正在加快提升其制造规模,我们与Lonza的合作将使我们能够制造尽可能多的mRNA-1273疫苗"。上周,该公司表示希望与Lonza达成为期10年的协议,使其能够每年生产多达10亿剂针对SARS-CoV-2的mRNA疫苗。

mRNA-1273是一种抗新型冠状病毒的信使核糖核酸(mRNA)疫苗,可针对病毒的刺突蛋白发挥作用。刺突蛋白是病毒感染宿主细胞的关键所在,也是过去研发严重急性呼吸综合征(SARS)冠状病毒疫苗和中东呼吸综合征(MERS)冠状病毒疫苗时的靶点。该疫苗在3月中旬开始了其I期临床研究。

今年4月,美国生物医学高级研究会发展局(BARDA)授予 Moderna高达4.83亿美元的资金,以加快COVID-19候选疫苗的开发。

原始出处:

https://www.firstwordpharma.com/node/1722235?tsid=4

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    2020-12-28 般若傻瓜
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    2020-05-08 公卫新人

    新冠肺炎,疫情何时才能消失

    0

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