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日药厂采免疫桥接认证新冠疫苗 by cloudblade

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日药厂采免疫桥接认证新冠疫苗
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日药厂采免疫桥接认证新冠疫苗

日本知名国价大药厂第一三共近日宣布,将以免疫桥接方式来替代三期临床试验。

日本可能是第一个采用免疫桥接方式来作为COVID-19疫苗紧急使用授权(EUA)标准的国家。

COVID-19病毒于去年爆发,全球疫情严峻,是COVID-19疫苗三期临床试验的黄金时期,但随越各种疫苗的施打,疫苗施打涵盖率的提升,要寻找适合COVID-19疫苗三期临床试验的区域并不容易,使用传统临床试验来检验新一代疫苗的效果将越来越不可行,免疫桥接势必成为疫苗三期试验的替代方案。

世界卫生组织(WHO)便于5 月底与各国开会讨论过,以免疫桥接来评估疫苗的效果。

之所以期望使用免疫桥接,有三大因素,其一是国际间之疫苗施打已有了一定的覆盖率,要寻找疫苗覆盖率低的地区和征招数万名志愿者来进行大规模的临床试验有其难度;其二,以传统临床试验让对照组受试者施打安慰剂,恐危害其安全;第三则是不公平。

当时的WHO会议仅为凝聚共识,直到近期,全球药政主管单位共组的国际药物法规主管机关联盟(ICMRA)召开研讨会,首度达成共识,若传统三期临床试验不可行,可以免疫桥接进行「非劣性试验」,以评估疫苗有效性。

故而,日本第一三共药厂宣布以此方式作为日本国产mRNA疫苗的临床试验。
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