Johnson & Johnson's Single-dose COVID-19 Vaccine Gets Conditional Marketing Authorization In EU

强生公司单剂新冠疫苗获欧盟有条件上市授权

2021-03-12 11:00:16 RTTNews

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Johnson & Johnson said Thursday that the European Commission has granted a Conditional Marketing Authorization for its single-dose COVID-19 vaccine. The authorization comes hours after receiving a positive opinion from the European Medicines Agency's the Committee for Medicinal Products for Human Use or CHMP for the vaccine. The CHMP earlier today recommended Conditional Marketing Authorization for the vaccine candidate, developed by Johnson & Johnson's Janssen Pharmaceutical, to prevent COVID-19 in individuals 18 years of age and older. Johnson & Johnson's single-dose COVID-19 vaccine is the fourth authorized vaccine available in the European union following two-dose vaccines developed by Pfizer/BioNTech, Oxford-AstraZeneca and Moderna. The Conditional Marketing Authorization is valid in all 27 member states of the European Union, plus Norway, Iceland and Liechtenstein. According to Johnson & Johnson, phase 3 ENSEMBLE study data showed that its COVID-19 vaccine was well tolerated and demonstrated a 67 percent reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination. Johnson & Johnson said the data also demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination. The company aims to begin delivery of its single dose COVID-19 vaccine to the EU in the second half of April and to supply 200 million doses to the EU, plus Norway and Iceland in 2021. In December 2020, the company announced that Janssen initiated a rolling submission with the EMA for its single-dose COVID-19 vaccine candidate, enabling an expedited CHMP review process. The COVID-19 vaccine candidate has also been filed for an Emergency Use Listing with the World Health Organization. Johnson & Johnson's single-dose COVID-19 vaccine received Emergency Use Authorization in the United States on February 27. The vaccine has also been granted Interim Order authorization in Canada. The company noted that the COVID-19 single-dose vaccine candidate is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. The vaccine is estimated to remain stable for two years at minus 15 degree celsius to minus 25 degree celsius and a maximum of three months at routine refrigeration at temperatures of 2 degree celsius to 8 degree celsius. For comments and feedback contact: editorial@rttnews.com Business News
强生公司周四表示,欧盟委员会已为其单剂新冠疫苗授予有条件的营销授权。 这项授权是在欧洲药品管理局的人用药品委员会或CHMP对疫苗的肯定意见后几个小时作出的。 CHMP今天早些时候建议有条件地批准由强生公司杨森制药公司开发的疫苗候选,用于在18岁及以上人群中预防COVID-19。 强生公司的单剂新冠疫苗是继辉瑞/生物技术公司、牛津-阿斯利康公司和Moderna公司研发的双剂疫苗之后,欧盟获得授权的第四种疫苗。 有条件的营销授权在欧盟所有27个成员国,加上挪威、冰岛和列支敦士登都有效。 据强生公司称,第三阶段集成研究数据显示,其新冠肺炎疫苗具有良好的耐受性,与服用安慰剂的参与者相比,接种新冠肺炎疫苗的参与者的症状性新冠肺炎疾病减少了67%。从接种后第14天开始观察到保护作用,并在接种后28天维持。 强生公司表示,数据还显示,该疫苗在所有研究地区预防严重疾病的有效性为85%,并且在接种后28天起,对与新冠肺炎相关的住院和死亡有保护作用。 该公司的目标是在4月下半月开始向欧盟交付单剂新冠疫苗,并在2021年向欧盟、挪威和冰岛供应2亿剂疫苗。 2020年12月,该公司宣布,杨森与EMA启动了其单剂COVID-19候选疫苗的滚动提交,从而实现了加速CHMP审查流程。新冠疫苗候选疫苗也已向世界卫生组织申请紧急用途清单。 强生公司的单剂新冠疫苗2月27日在美国获得紧急使用授权。该疫苗在加拿大也获得了临时订单授权。 该公司指出,新冠单剂量候选疫苗与标准疫苗储存和分销渠道兼容,易于向偏远地区运送。这种疫苗估计可在零下15摄氏度至零下25摄氏度的环境下稳定两年,在2摄氏度至8摄氏度的温度下常规冷藏最多可稳定三个月。 如需评论和反馈,请联系:editorial@rttnews.com 商业新闻

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