《RSV疫苗获得FDA的里程碑式批准》

  • 来源专题:生物医药
  • 编译者: 杜慧
  • 发布时间:2023-06-05
  • 美国FDA已经批准了两种基于蛋白质的RSV疫苗,这是近60年来药物开发者一直无法企及的一个里程碑。在对一种关键的RSV表面蛋白进行突破性的结构研究后的十年里,这些疫苗获得了批准,从而使该管道重新焕发活力。

    呼吸道合胞病毒 (RSV) 是一种常见的感染,通常会引起轻微的呼吸道症状,但在5岁以下的儿童以及体弱老年人中可能会引发危及生命的下呼吸道疾病(LRTD)。

    葛兰素史克公司的Arexvy和辉瑞公司的Abrysvo都获得了用于60岁以上患者的批准,其依据是仍在进行的III期试验的中期结果。锡耶纳生物技术基金会科学主任、葛兰素史克疫苗公司前首席科学家Rino Rappuoli说:"这两种疫苗似乎都很好,将成为疫苗组合中巨大的新成员。“

    辉瑞公司的疫苗也可能很快在孕产妇方面获得批准;当孕妇接受免疫接种时,她们会产生穿过胎盘的中和抗体,为婴儿出生后的头几个月提供保护。美国FDA咨询小组最近建议在这种情况下予以批准。该机构将于8月作出决定。

    其他正在进行临床试验的RSV疫苗包括Moderna公司的mRNA候选疫苗,它应该在几个月内提交给美国监管机构。强生公司最近在 "评估[RSV]疫苗情况 "之后,撤回了其腺病毒疫苗候选项目。

    预计到2028年,全球RSV疫苗的销售额将达到35亿美元.


  • 原文来源:https://www.nature.com/articles/d41573-023-00085-x?error=cookies_not_supported&code=98d57db1-2dba-42f7-9283-cb41d2bfa25d
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