强生新冠疫苗进入III期临床试验,大选前疫苗出炉有望吗?

2020-10-02 林怡龄 亿欧

在阿斯利康、辉瑞/BioNTech、Moderna的新冠疫苗吸引外界焦点之时,还有不少制药公司也在推动新冠疫苗的研发。

在阿斯利康、辉瑞/BioNTech、Moderna的新冠疫苗吸引外界焦点之时,还有不少制药公司也在推动新冠疫苗的研发。

7月16日,强生曾宣布,在研新冠疫苗的最终阶段临床试验最快提前至9月。如今,其临床试验的开展已如期而至。据外媒23日报道,强生宣布了其新冠疫苗JNJ-78436735启动大规模的国际III期试验。

受此消息影响,强生盘前一度涨超3%,开盘后高开,股价一度突破147美元。

据外媒报道,这是一项随机双盲安慰剂对照的临床试验。该实验将在美国、阿根廷、巴西、智利等216个国家和地区进行,通过招募6万多名成年志愿者,评估在研新冠疫苗在6万名18岁及以上成年人,包括60岁以上的人群中,单剂疫苗与安慰剂的安全性和有效性。这6万名志愿者当中,包括了患有其他疾病的人群,以便尽可能囊括各种高风险和多样化的人群。

据悉,JNJ-78436735由强生子公司Janssen使用AdVac技术平台开发,该平台还用于开发在欧洲获批的埃博拉疫苗,以及寨卡病毒、呼吸道合胞病毒(RSV)和艾滋病病毒(HIV)等候选疫苗。

行业媒体Biospace认为,如果强生该疫苗获得批准,将比其他候选新冠疫苗有更多优势。业内表示,强生的候选疫苗可以在-20°C的环境里保存两年,在2-8℃可以保存至少三个月。而其他的候选疫苗,有些需要在-80°C下保存,有些则需要在-60°C保存。而这将给疫苗的配送物流带来一定压力。

另外,强生的JNJ-78436735只需单剂注射,而不需要像其他候选疫苗一样间隔28天,注射2次。

在此前临床试验得到批准后,强生便成为了美国政府“曲速行动”(美国新冠疫苗研发计划)支持的III期临床试验制药商。除此之外,Moderna、辉瑞和阿斯利康亦在名单里。今年8月份,美国政府也与强生达成了一项价值超过10亿美元的协议,以确保获得1亿剂该公司的实验性新型冠状病毒疫苗。

强生表示,预计将在2021年初向公众提供用于紧急授权的疫苗批次。其表示将继续扩大生产能力,并努力实现每年提供十亿剂疫苗的目标。

不过,随着美国总统特朗普坚持要求在11月3日总统大选之前提供疫苗,FDA正在考虑收紧对新冠疫苗的紧急使用授权(EUA),实施更严格的标准,以此缓解药企们的担忧——许多专家和药企表示不太可能在总统大选前提供疫苗,他们皆承诺要遵守最严格的科学程序。其中一些企业还公布了它们的临床试验计划书,提高透明度。

同一天(23日),华尔街日报有消息称,美国卫生监管机构已经起草了新冠疫苗的紧急使用授权的指导方针。拟议的要求中,接种新冠疫苗后的感染率要比安慰剂降低50%。监管机构已经要求,任何新冠疫苗必须定期获得批准。

知情人士称,FDA已经于上周向美国卫生与公众服务部部长亚历克斯·阿扎(Alex Azar)提交了该计划草案,以供审核。他还表示,白宫管理和预算办公室也在审核该计划。而如果特朗普政府签署了指导方针,那就意味着其很难在选举日之前授权紧急使用疫苗。

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    2021-07-26 juliusluan78
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    2020-10-02 公卫新人

    新冠肺炎,疫情何时才能消失

    0

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