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Params: post, 584065, a:5:{i:0;s:387:"美国FDA可能最终会批准阿斯利康的疫苗,但辉瑞/拜恩泰科以及Moderna新冠疫苗美国供应是会保证充足的,在这样的情况下,后来获批的疫苗厂商很难渗透市场。期待已久的阿斯利康新冠疫苗大规模临床试验结果周三正式公布在《新英格兰医学杂志》(NEJM)上。数据显示,阿斯利康的新冠疫苗在";i:1;a:4:{s:3:"tag";s:1:"b";s:6:"option";N;s:8:"original";a:2:{i:0;s:3:"[B]";i:1;s:4:"[/B]";}s:8:"children";a:1:{i:0;s:97:"预防有症状的疾病方面有效性为74%,在65岁及以上的人群中有效性为83.5%。";}}i:2;s:219:"
数据公布后,阿斯利康周三股价收盘大涨3.5%,该公司今年以来股价涨幅接近20%。不过市场认为,在mRNA主导美国新冠疫苗市场的背景下,留给新进厂商的机会甚微。
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阿斯利康新冠疫苗大规模临床试验结果公布在《新英格兰医学杂志》上
阿斯利康该数据调查了美国、智利和秘鲁的26000多名志愿者,他们接种了两剂疫苗,间隔约一个月。在接种疫苗的17600多名参与者中没有出现严重或危重症状的新冠病例,而接种安慰剂的8500名志愿者中,严重或危重症病例达到8例。安慰剂组有两人死亡,接种疫苗的人中没有人死亡。
三期临床74%的总体有效性低于该公司在3月份报告的中期试验79%的有效性,当时有卫生官员罕见地空开指责该数据基于“过时信息”。
数据公布后,业内反应平淡。生物基金公司Loncar Investments创始人布拉德•隆卡(Brad Loncar)对第一财经记者表示:“具有讽刺意义的是这一消息在美国竟然没有引起特别的关注,所以我不认为这款疫苗会最终在美国使用。”
隆卡表示,美国FDA可能最终会批准阿斯利康的疫苗,但现在看来,辉瑞/拜恩泰科(BioNTech)以及Moderna新冠疫苗美国供应是会保证充足的,在这样的情况下,后来获批的疫苗厂商很难渗透市场。
出于商业考虑,法国制药巨头赛诺菲已经宣布放弃与辉瑞和Moderna争夺mRNA疫苗市场,赛诺菲认为,全球mRNA新冠疫苗已经出现了主导者,现在再进行三期临床试验的意义不大。
与辉瑞/拜恩泰科和Moderna的mRNA疫苗不同,阿斯利康的疫苗为腺病毒载体疫苗,价格低廉,物流简便,有助于推动在全球范围的疫苗接种。截至目前,阿斯利康疫苗已获准在全球170多个国家和地区使用。
阿斯利康的疫苗是全球首批进入大规模生产的疫苗之一,但其在美国和欧洲等重要市场的发展一直遭遇不顺,今年3月,一些阿斯利康疫苗的接种者报道了多起血凝事件,这导致了多个欧洲国家一度暂停了该疫苗的使用;美国也迟迟没有批准该疫苗上市。
阿斯利康曾在今年7月底表示,它计划向美国FDA申请新冠疫苗的全面批准,而不是寻求紧急使用授权。阿斯利康CEO帕斯卡尔·索里奥特 (Pascal Soriot) 在当时的发布会上表示,他希望疫苗仍能在美国发挥作用,尽管这一过程比预期的要长。
一位阿斯利康发言人表示,该公司预计将在今年晚些时候申请美国批准。该公司还在为已经接种两剂辉瑞/拜恩泰科或Moderna疫苗的人探索加强剂的接种方案。";}, 1621686945, 1716084391
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