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Second Chinese Vaccine Wins Conditional-Use Approval
Published on: 2021-02-09
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China's drug authorities have given "conditional" approval for a second COVID-19 vaccine, Sinovac's CoronaVac jab, the pharmaceutical company said Saturday.

The vaccine has already been rolled out to key groups at higher risk of exposure to coronavirus but Saturday's approval allows for its use on the general public.

A conditional approval helps hustle emergency drugs to market in cases when clinical trials are yet to meet normal standards but indicate therapies will work.

The approval comes after multiple domestic and overseas trials of the vaccine in countries including Brazil and Turkey, although "efficacy and safety results need to be further confirmed", Sinovac said in a statement.

Fellow Chinese pharmaceutical company Sinopharm received a similar conditional green light in December to put its vaccine on the market.

Sinovac said trials in Brazil had shown around 50 per cent efficacy in preventing infection and 80 per cent efficacy in preventing cases requiring medical intervention.

Meanwhile Sinopharm said in December that its vaccine had a 79.34 per cent efficacy rate, lower than rival jabs developed in the West by Pfizer-BioNTech and Moderna -- with 95 and 94 percent rates respectively.

China has been racing to develop homegrown jabs and aims to vaccinate 50 million people before the start of the Lunar New Year in mid-February.

The holiday normally spurs a travel rush with hundreds of millions traversing the country -- though authorities are encouraging people to stay home this year through a mixture of restrictions and incentives.

我国又一款新冠疫苗获得附条件上市批准

继国药集团新冠疫苗获得附条件上市后,北京科兴中维生物技术有限公司的新冠病毒灭活疫苗"克尔来福"2月5日获批附条件上市,成为我国获批的第二款新冠病毒疫苗。

国家药监局根据"疫苗管理法"、"药品管理法"相关规定,按照药品特别审批程序,进行应急审评审批,附条件批准上市注册申请。国家药监局要求该疫苗上市许可持有人继续开展相关研究工作,完成附条件的要求,及时提交后续研究结果。

该疫苗用新冠病毒(CZ02株)接种非洲绿猴肾细胞(简称Vero细胞),经培养、收获病毒液、灭活病毒、浓缩、纯化和氢氧化铝吸附制成,不含防腐剂。疫苗的基础免疫程序为2剂次,间隔14天至28天,每一次人用剂量为0.5毫升。

 

 

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