国产新冠灭活疫苗通过世卫组织紧急使用认证

当地时间5月7日，世界卫生组织宣布，由中国医药集团北京生物制品研究所研发的新冠灭活疫苗正式通过世卫组织紧急使用认证。

 

"This afternoon, the WHO gave emergency use listing to Sinopharm Beijing's COVID-19 vaccine¹, making it the sixth vaccine to receive WHO validation² for safety, efficacy and quality," said WHO Director General Dr. Tedros Adhanom Ghebreyesus at a press briefing.

世卫组织总干事谭德塞在新闻发布会上说，世卫组织当天下午为中国国药新冠疫苗颁发了紧急使用认证，使其成为第6种获得世卫组织安全性、有效性和质量验证的新冠疫苗。

 

"This expands the list of vaccines³ that COVAX can buy and gives countries confidence to expedite their own regulatory approval, and to import and administer a vaccine," he said.

这扩大了世卫组织主导的“新冠肺炎疫苗实施计划”（COVAX）组合的疫苗库名单，并有助于各国加快对新冠疫苗的监管审批以及进口和接种疫苗。

 

世卫组织负责获得药品和卫生产品的助理总干事玛丽安热拉·西芒当天在一份声明中表示，

 

The addition of the Sinopharm vaccine has "the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk".

将中国国药新冠疫苗纳入世卫组织紧急使用清单“有助于寻求保护卫生工作者和高危人群的国家加速获得新冠疫苗”。

 

The jab produced by the Beijing Bio-Institute of Biological Products Co. Ltd., a subsidiary of the China National Biotec Group, is an inactivated⁴ vaccine with easy storage requirements, which makes it highly suitable for use in low-resource settings.

中国医药集团北京生物制品研究所研发的新冠灭活疫苗易于储存，使其非常适用于资源匮乏的环境。

 

It is also the first vaccine that will carry a vial monitor, a small sticker on the vials that changes color if the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used.

它也是第一款携带疫苗瓶监测器的疫苗，疫苗瓶上的小标签会因疫苗受热而改变颜色，便于卫生工作者判断疫苗是否安全可用。

 

According to the WHO's Strategic Advisory⁵ Group of Experts on Immunization (SAGE), the Sinopharm vaccine is recommended for use in adults 18 years and older in a two-dose schedule with a spacing of three to four weeks.

根据世卫组织免疫战略咨询专家组的意见，世卫组织建议将中国国药新冠疫苗用于18岁及以上成年人，采用两剂注射、间隔时间为3至4周。

 

The WHO is not recommending an upper age limit for the Sinopharm vaccine, because reviewed data have suggested that the vaccine is likely to have a protective effect in older persons, according to the WHO press release.

世卫组织不建议对中国国药新冠疫苗设置使用年龄上限，因为评估数据显示，该疫苗对老年人可能也有保护作用。

 

The WHO had previously⁶ listed the COVID-19 vaccine developed by Pfizer/BioNTech, two versions of the AstraZeneca/Oxford vaccine, the Janssen vaccine and the Moderna vaccine for emergency use.

此前，世卫组织已向5种新冠疫苗颁发紧急使用认证，分别是美国辉瑞制药有限公司和德国生物新技术公司联合研发的新冠疫苗、英国阿斯利康制药公司和牛津大学联合研发的两个版本阿斯利康疫苗、美国强生公司旗下杨森制药公司研发的新冠疫苗以及美国莫德纳公司研发的新冠疫苗。

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