Merck receives FDA approval for Ebola vaccine


2019-12-20 10:47:12 YAHOO!FINANCE


- The U.S. Food and Drug Administration said on Thursday it granted approval to drugmaker Merck & Co's Ebola vaccine Ervebo, making it the first FDA-approved vaccine against the deadly virus. The vaccine was used by the World Health Organization and Democratic Republic of the Congo as an investigational vaccine to help reduce Ebola virus disease (EVD) outbreaks in few West African countries from 2014 to 2016. The Ebola virus, which causes haemorrhagic fever and spreads from person to person through direct contact with body fluids, has killed more than 2,100 people in Congo since the middle of the year, making it the second-largest Ebola outbreak in history. The vaccine, which is administered as a single-dose injection, will help to prevent EVD caused by Zaire ebolavirus in patients aged 18 years and older, the regulator said in a statement. In November, Merck received approval from the European Commission to market Ervebo, less than a month after a European medicines panel backed the first-ever vaccine against the virus. Merck did not immediately respond to a request for comment, after market hours. (Reporting by Maria Ponnezhath in Bengaluru; Editing by Subhranshu Sahu)
-美国食品药品监督管理局(Food and Drug Administration)周四表示,它已批准制药商默克公司(默克(Merck)& Co .)的埃博拉(Ebola)疫苗二韦博( Ervebo ),使其成为首个获得 FDA 批准的针对致命病毒的疫苗。 该疫苗被世界卫生组织和刚果民主共和国用作调查疫苗,以帮助减少2014年至2016年期间西非少数国家爆发的埃博拉(Ebola)病毒疾病。 埃博拉病毒引起出血热,通过直接接触体液从人到人传播,自年中以来已在刚果造成2100多人死亡,成为历史上第二大埃博拉(Ebola)疫情。 该监管机构在一份声明中表示,这种疫苗是单剂量注射,将有助于预防18岁及以上患者因扎伊尔埃博拉病毒引起的 EVD 。 11月,默克(Merck)公司获得欧盟委员会( European Commission )批准上市厄维博( Ervebo ),不到一个月前,一个欧洲药品小组就支持了有史以来第一个针对该病毒的疫苗。 默克(Merck)公司在上市后没有立即回应置评请求。 ( Maria Ponnezhath 在 Bengaluru 的报道; Subhranshu Sahu 的编辑)