国药集团新冠灭活疫苗在巴林获批上市

据巴林国家卫生监管局官方消息，在G42 Healthcare(中国国药集团在中东和北非的独家经销商)提交了上市所需相关文件后，巴林国家卫生监管局已正式批准国药集团中国生物研发的新冠灭活疫苗在巴林王国注册上市。以下是官方原文：

National Health Regulatory Authority approves Sinopharm COVID-19 vaccine

Manama, Dec. 13 (BNA): The National Health Regulatory Authority (NHRA) today announced it has officially approved the registration of Sinopharm’s COVID-19 vaccine after the submission of all related documentation by G42 Healthcare, the company’s exclusive distributor in the Middle East and North Africa.

The NHRA’s decision to approve and use the vaccine is based on the clinical trials data conducted across several countries, which was thoroughly reviewed and evaluated by the Authority. Results from Phase III clinical trials showed an 86% efficacy rate, a 99% seroconversion rate of neutralizing antibody and 100% effectiveness in preventing moderate and severe cases of COVID-19, following testing on 42,299 volunteers

The NHRA further verified the quality of the vaccine by reviewing the scientific data behind the manufacturing process and the stability of the product, in addition to ensuring the manufacturer's commitment to applying the principles of Good Manufacturing Practice (GMP), in accordance to international standards in the pharmaceutical industry and requirements issued by the NHRA.

Additionally, the NHRA also consulted with the Clinical Research Committee at NHRA, comprised of medical specialists, researchers, academics and doctors, also responsible for approving clinical trials, as well as the approval of the immunization committee.

It is worth noting that the Kingdom of Bahrain has participated in Phase III clinical trials of the vaccine as part of the 4 Humanity campaign, in which more than 7,700 volunteers signed up. The Authority had previously authorized the emergency use of Sinopharm’s vaccine based on preliminary results, which was provided to frontline professionals in contact with COVID-19 patients.

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内容来源|巴林国家卫生监管局、国药集团

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