今天阿斯利康（AstraZeneca）宣布，腺病毒载体新冠疫苗AZD1222在美国进行的3期临床试验中获得积极结果。中期分析显示，AZD1222在预防出现症状的COVID-19方面效力达到79%，在预防严重疾病和住院方面效力达到100%。
临床在美国、秘鲁和智利进行，招募32449名受试者，疫苗、安慰剂以2:1的比例，间隔4周接种两剂疫苗，共出现141例有症状新冠患者供分析。
数据初步看起来非常好，但刚刚发布，DSMB明显不满，向多家机构告状，该临床可能包含过时信息outdated information，可能导致有效性分析数据不完整。NIAID美国国家过敏和传染病研究所，也就是福奇博士所在机构，罕见发声明对阿斯利康疫苗表达担忧。
Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.
Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees.
阿斯利康这个疫苗真实波折不断，跳过一期临床数据下，全球首个快速启动万人规模二三期临床试验，结果给药剂量出现乌龙，错误剂量组反而效果更好；一针法结果不作任何披露……疑似血栓不良反应事件多国停用（欧盟现在已经确认安全放行），现在又被美国权威官方机构公开发文怼…
AZ的临床部门不知是不是流程和管理是否出现了重大问题？
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