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Hayat – Vax成为在越南获批的第七种新冠疫苗

2021-09-10 17:13

Hayat – Vax成为在越南获批的第七种新冠疫苗 hinh anh 1 Hayat – Vax疫苗。图自越通社

越南卫生部9月10日发布了第4361/QĐ-BYT号决定,有条件批准 Hayat – Vax疫苗紧急使用。

 Hayat – Vax疫苗由中国生物技术股份有限公司旗下北京生物制品研究所有限公司生产的半成品。

该疫苗在阿拉伯联合酋长国 Julphar(Gulf Pharmaceutical Industries)进行初级包装、次级包装和出厂,并由越南Vimedimex医药制品股份公司提交申请资料。

Hayat - Vax 疫苗每 0.5 毫升剂量含有 6.5 单位灭活的 SARS-CoV-2 抗原(vero 细胞),为注射用悬浮液。该疫苗有单支两剂包装和单支单剂包装等的两种包装方式。

卫生部同时就批准Hayat – Vax紧急使用的条件作出了明确规定。

越南药品管理局在收到进口商的档案资料之后有责任按规定发放进口Hayat – Vax疫苗许可证,并严格执行有关进口疫苗质量管理和进口管理的法律规定。

越南科学技术和培训局在征集卫生部疫苗和生物制品咨询委员会意见的基础上有责任筛选具备条件的单位对疫苗在使用过程中的安全性和有效性进行评估。

预防卫生局按规定进行有关接种Hayat – Vax的责任。国家疫苗和生物制品检定局负责进行疫苗检定并在投入使用前发放Hayat – Vax疫苗出厂许可证。

截至目前,共有7种疫苗在越南获批并进行接种,包括阿斯利康公司的阿斯利康疫苗、Gamaleya 研究所的Sputnik V疫苗、Johnson & Johnson的COVID-19 Vaccine Janssen疫苗、COVID-19 Vaccine Moderna的Spikevax疫苗、辉瑞的Comirnaty疫苗、中国国药集团China National Biotec Group (CNBG)/Sinopharm的Vero Cell疫苗和Hayat – Vax疫苗。(完)

越通社
 

 

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