AZD1222 vaccine met primary 功效 endpoint in preventing COVID-19

This announcement contains inside information

23 November 2020 07:00 GMT
 

两种不同的给药方案显示出疗效,其中一种显示出更好的轮廓

在接受AZD1222治疗的参与者中没有住院或严重的COVID-19病例
 

在英国和巴西进行的AZD1222临床试验中期分析结果显示,该疫苗对预防COVID-19非常有效, the primary endpoint, 在接种疫苗的参与者中,没有住院治疗或严重病例的报告. T在这里 were a total of 131 COVID-19 cases in the interim analysis.

One dosing regimen (n=2,741) showed vaccine 功效 of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen (n=8,895) showed 62% 功效 when given as two full doses at least one month apart. 两种给药方案(n=11,636)的联合分析结果显示,平均疗效为70%. All results were statistically significant (p<=0.0001). 更多的 data will continue to accumulate and additional analysis will be conducted, refining the 功效 reading and establishing the duration of protection.

一个独立的数据安全监测委员会确定,该分析符合其主要终点,显示在接种两剂疫苗后14天或更长时间内对COVID-19具有保护作用. No serious safety events related to the vaccine have been confirmed. AZD1222 was well tolerated across both dosing regimens.

澳门葡京网赌游戏现在将立即准备向世界各地的监管机构提交数据,这些机构已制定了有条件或早期批准的框架. 该公司将向世界卫生组织申请紧急用途清单,以加快在低收入国家获得疫苗的途径. 并行, 中期结果的完整分析已提交到同行评议的期刊上发表.

Professor Andrew Pollard, Chief Investigator of the Oxford Vaccine Trial at Oxford, 他说:“这些发现表明,澳门葡京赌博游戏有一种有效的疫苗,可以挽救许多生命. 振奋人心地, 澳门葡京赌博游戏发现其中一种给药方案可能有90%左右的有效性如果使用这种给药方案, more people could be vaccinated with planned vaccine supply. 今天的宣布多亏了澳门葡京赌博游戏试验中的许多志愿者,  以及在世界各地辛勤工作、才华横溢的研究团队.”

帕斯卡Soriot, Chief Executive Officer, said: “Today marks an important milestone in our fight against the pandemic. 该疫苗的有效性和安全性证实,它将对COVID-19非常有效,并将对这一突发公共卫生事件产生直接影响. 此外, 疫苗的供应链简单,澳门葡京赌博游戏的不盈利承诺和承诺广泛, equitable and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval.”

汇总分析包括来自英国COV002 II/III期试验和巴西COV003 III期试验的数据. 在23日,000名参与者在接受半剂量/全剂量方案或两次全剂量AZD1222方案或比较物治疗后接受评估, meningococcal conjugate vaccine called MenACWY or saline. 全球试验正在评估来自不同种族和地理群体的18岁或以上的参与者,他们健康或有稳定的基础医疗条件.

Clinical trials are also being conducted in the US, 日本, 俄罗斯, 南非, Kenya and Latin America with planned trials in other European and Asian countries. In total, the Company expects to enrol up to 60,000 participants globally.

该公司在生产方面进展迅速,到2021年可实现30亿剂疫苗的滚动生产能力, pending regulatory approval. The vaccine can be stored, 在正常冷藏条件下(2-8摄氏度/ 36-46华氏度)运输和处理至少6个月,并在现有的医疗保健环境中进行管理.

澳门葡京网赌游戏 continues to engage with governments, 世界各地的多边组织和合作者确保在大流行期间广泛和公平地获得无利润的疫苗.

COV002

COV002 is a single-blinded, 的多中心, 随机, controlled Phase II/III trial assessing the safety, 功效 and immunogenicity of AZD1222 in 12,390 participants in the UK. Trial participants to date are aged 18 years or over, 健康或患有医学上稳定的慢性疾病,并且暴露于SARS-CoV-2病毒的风险增加的人. Participants receive one or two intramuscular doses of a half dose (~2.5 x1010 viral particles) or full dose (~5x1010 viral particles) of AZD1222 or comparator, meningococcal vaccine MenACWY. 在接种疫苗后最多一年的多个时间点抽取参与者的血液样本并对安全性和免疫原性进行临床评估. 对出现相似症状的疑似病例进行COVID-19 PCR病毒学确认检测. 除了, 每周拭子检测感染并评估疫苗抗感染效力.

COV003

COV003 is a single-blinded, 的多中心, 随机, controlled Phase III trial assessing the safety, 功效, and immunogenicity of AZD1222 in 10,300 participants in Brazil. Trial participants to date are aged 18 years or over, 健康或患有医学上稳定的慢性疾病,并且暴露于SARS-CoV-2病毒的风险增加的人. 参与者随机接受两次全剂量(~5x10)肌内注射10 viral particles) of AZD1222 or comparator, meningococcal vaccine MenACWY as first dose and a saline placebo as second dose. 在接种疫苗后最多一年的多个时间点抽取参与者的血液样本并对安全性和免疫原性进行临床评估. 对出现相似症状的疑似病例进行COVID-19 PCR病毒学确认检测.

AZD1222
AZD1222是由牛津大学及其衍生公司Vaccitech共同发明的. 它使用了一种复制缺陷的黑猩猩病毒载体,该载体基于一种普通感冒病毒(腺病毒)的弱化版本,这种病毒会导致黑猩猩感染,并含有SARS-CoV-2病毒刺突蛋白的遗传物质. After vaccination, the surface spike protein is produced, 一旦SARS-CoV-2病毒感染人体,就启动免疫系统攻击它.

澳门葡京网赌游戏

澳门葡京网赌游戏 (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - 肿瘤学, Cardiovascular, 肾 & Metabolism, and 呼吸 & 免疫学. Based in 剑桥, UK, 澳门葡京网赌游戏在100多个国家开展业务,其创新药物被全球数百万患者使用. 请访问 澳门葡京网赌游戏.com and follow the Company on 推特 @澳门葡京网赌游戏.

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艾德里安·坎普
Company Secretary
澳门葡京网赌游戏 PLC

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