Johnson & Johnson' Single-dose COVID-19 Vaccine Recommended For Use In EU


2021-03-12 00:00:15 RTTNews


Johnson & Johnson said that its single-dose COVID-19 vaccine candidate has received a positive opinion from the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA. The CHMP has 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. The vaccine will be the fourth to be authorized for use in the European union following the Pfizer/BioNTech, Oxford-AstraZeneca and Moderna COVID-19 vaccines. Johnson & Johnson said that phase 3 ENSEMBLE study 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. 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. 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. According to Johnson & Johnson, 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: Health News
强生公司说,其单剂量新冠疫苗候选产品已获得来自人用药用产品委员会或欧洲药品管理局CHMP或EMA的肯定意见。 CHMP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。 该疫苗将是继辉瑞/Biontech、牛津-阿斯利康和Moderna之后第四款获授权在欧盟使用的新冠肺炎疫苗。 强生公司表示,第三阶段集成研究显示,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,接种疫苗的参与者出现的新冠肺炎症状减少了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。 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%,并显示了对接种后28天开始的新冠肺炎住院和死亡的保护作用。 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。 据强生公司介绍,新冠单剂疫苗候选疫苗兼容标准疫苗储存和分销渠道,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 健康新闻