美国FDA批准辉瑞/BioNTech新冠疫苗用于12-15岁青少年

2021-05-11 JACKZHAO MedSci原创

当地时间5月10日,美国FDA扩大了辉瑞新冠疫苗的紧急使用授权范围,将包括12至15岁的青少年人群。

Under the Pfizer-BioNtech deal, the 27 EU countries could buy 200 million doses, and have an option to purchase another 100 million.

当地时间5月10日,美国FDA扩大了辉瑞新冠疫苗的紧急使用授权范围,将包括12至15岁的青少年人群。

这是美国首款授权用于年轻人和青少年的新冠疫苗; 该疫苗先前已获准用于16岁及以上的人群。 来自Moderna和强生的新冠疫苗已授权在18岁及以上的人群中使用。

为了支持扩大使用范围,FDA审查了辉瑞公司提交的最新数据。 该公司在三月底表示,一项涉及2,260名12至15岁儿童的临床试验表明,该疫苗的功效为100%,并且耐受性良好。

“这是一个相对简单的决定,” FDA监管疫苗的分支机构FDA生物制品评估和研究中心主任彼得·马克斯博士周一晚对记者说。FDA查看了辉瑞的安全性和有效性数据。 该机构还研究了一些接种疫苗的儿童的免疫反应,并将其与接种疫苗的年龄较大的青少年和成年人的免疫反应进行了比较。马克斯说:“对这种疫苗的反应非常好,实际上,在年轻的年龄组中,甚至比在16-25岁的年龄组中要好得多。”“ 12至15岁的儿童的安全性与16至25岁的儿童非常相似。”

但FDA的独立疫苗和相关生物产品咨询委员会未举行会议,就是否建议将EUA扩大至12至15岁儿童进行表决。但是,美国疾病预防控制中心免疫实践咨询委员会定于周三开会,就是否建议在该年龄段使用这种疫苗向疾病预防控制中心提供建议。 疾病预防控制中心主任Rochelle Walensky博士然后将决定该机构是否建议在新的小组中使用该疫苗。

FDA在周一的一份声明中说:“在会议期间,该机构将提供有关我们的COVID-19疫苗紧急使用授权(EUA)方法的状态更新,该疫苗打算在12至17岁的个人中使用。”“委员会还将讨论支持EUA和用于12岁以下儿童的COVID-19疫苗的生物制剂许可证申请(BLA)所需的数据。委员会将不会讨论任何特定产品。”添加 BLA意味着将获得FDA的完全批准。

目前已批准Moderna和强生公司生产的疫苗可用于18岁及以上的人群。马克斯在一份声明中说:“我们认识到下一个关键步骤是使疫苗可在整个儿科人群中使用。”“与最初的COVID-19疫苗授权一样,我们希望确保公众清楚地理解我们对支持紧急使用授权和用于预防COVID-19的疫苗的生物许可证申请所需要的数据和信息的期望在这个儿童年龄范围内。”

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    2022-02-23 shock_melon
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    2021-05-18 sunylz
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    2021-10-23 bugit
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    2021-05-11 公卫新人

    新冠肺炎,疫情何时才能消失

    0

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