U.S. Trial Confirms AstraZeneca Vaccine Is Safe And Highly Effective


2021-03-22 23:30:21 RTTNews


In a major development that helps ease tension in the country's anti-Covid vaccination campaign, results from the much-awaited U.S. trial of the Oxford-AstraZeneca vaccine confirmed that it is both safe and highly effective. "The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation," the UK-based pharmaceutical and biotechnology giant said in a statement. This interim safety and efficacy analysis was based on a trial in which more than 32,000 volunteers took part. The independent data safety monitoring board (DSMB) found no increased risk of side effects such as blood clot and cerebral venous sinus thrombosis among the 21,583 participants receiving at least one dose of the vaccine. Ann Falsey, Professor of Medicine, University of Rochester School of Medicine, US, and co-lead Principal Investigator for the trial, said, "These findings reconfirm previous results observed in AZD1222 trials across all adult populations but it's exciting to see similar efficacy results in people over 65 for the first time. Mene Pangalos, Executive Vice President (BioPharmaceuticals R&D) at AstraZeneca, said, "These results add to the growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups". The company will submit these findings to the US Food and Drug Administration to be considered for Emergency Use Authorization. If granted, it will pave the way for the rollout of millions of doses across the United States. The European Medicines Agency last week concluded that AstraZeneca's COVID vaccine is "safe and effective". An extraordinary meeting of the EU medicines regulator on Thursday gave the go-ahead on the continued use of the COVID-19 vaccine. 13 European countries had either temporarily halted AstraZeneca vaccine inoculations or delayed its roll out as a precaution following reports of patients developing blood clots after receiving AstraZeneca vaccine jabs. For comments and feedback contact: editorial@rttnews.com Health News
这是一项重大进展,有助于缓解该国抗COVID疫苗接种运动中的紧张局势,这是期待已久的牛津-阿斯利康在美国的试验结果 疫苗证实它既安全又高效。 “阿斯利康美国AZD1222的III期试验显示,具有统计学意义的AZD1222疫苗在预防症状性COVID-19方面的有效性为79%,在预防症状性COVID-19方面的有效性为100% 预防严重疾病和住院治疗,“这家总部位于英国的制药和生物技术巨头在一份声明中说。 这项临时性的安全性和有效性分析是基于一项超过32,000名志愿者参与的试验。 独立数据安全监测委员会(DSMB)在21583名患者中没有发现任何副作用风险增加,如血凝块和脑静脉窦血栓形成 接受至少一剂疫苗的参与者。 美国罗切斯特大学医学院医学教授、该试验的联合首席研究员安·法尔西说:“这些发现再次证实了 以前的结果在AZD1222试验中观察到了所有成人群体,但在65岁以上的人群中首次看到类似的疗效结果是令人兴奋的。 阿斯利康执行副总裁(生物制药研发)Mene Pangalos说:“这些结果增加了越来越多的证据,表明这种疫苗是 对COVID-19的所有严重情况和所有年龄组都有良好的耐受性和高度的有效性“。 该公司将把这些发现提交给美国食品和药物管理局,以考虑获得紧急使用授权。如果得到批准,它将为 在美国各地投放了数百万剂。 欧洲药品管理局上周得出结论,阿斯利康的COVID疫苗是“安全有效的”。欧盟药品监管机构的一次特别会议 周四,新冠肺炎疫苗的继续使用获得了批准。 13个欧洲国家或暂时停止了阿斯利康疫苗的接种,或推迟了阿斯利康疫苗的推广,作为预防措施 注射阿斯利康疫苗后的血凝块。 如需评论和反馈,请联系:editorial@rttnews.com 健康新闻