这份公告包含内幕消息
2020年11月23日07:00 GMT
Two different dosing regimens demonstrated 功效 with one showing a better profile
No hospitalisations or severe cases of COVID-19 in participants treated with AZD1222
Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, 主要终点, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. 中期分析共发现131例COVID-19病例.
一个给药方案(n=2),(741) AZD1222作为半剂量给药时，疫苗效力为90%, 然后至少间隔一个月服用一次全剂量, 另一个给药方案(n=8),895)当两次全剂量至少间隔一个月时显示62%的疗效. The combined analysis from both dosing regimens (n=11,636) resulted in an average 功效 of 70%. All results were statistically significant (p<=0.0001). 将继续积累更多的数据，并进行进一步的分析, 精细化功效读数，建立保护时间.
An independent Data Safety Monitoring Board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine. 目前尚未确认与该疫苗有关的严重安全事件. AZD1222在两种给药方案中均具有良好的耐受性.
澳门葡京网赌游戏 will now immediately prepare regulatory submission of the data to authorities around the world that have a framework in place for conditional or early approval. The Company will seek an Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries. 并行, the full analysis of the interim results is being submitted for publication in a peer-reviewed journal.
安德鲁·波拉德教授, 牛津疫苗试验的首席研究员, said: “These findings show that we have an effective vaccine that will save many lives. 振奋人心地, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, 更多的人可以通过计划的疫苗供应接种疫苗. Today’s announcement is only possible thanks to the many volunteers in our trial, and the hard working and talented team of researchers based around the world.”
帕斯卡Soriot, 首席执行官, 他说:“今天是澳门葡京赌博游戏抗击疫情的一个重要里程碑. This vaccine’s 功效 and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency. 此外, the vaccine’s simple supply chain and our no-profit pledge and commitment to broad, 公平和及时的获取意味着可以负担得起并在全球范围内获得, 在获得批准的情况下供应数亿剂药物.”
The pooled analysis included data from the COV002 Phase II/III trial in the UK and COV003 Phase III trial in Brazil. 在23日,000 participants are being assessed following two doses of either a half-dose/full-dose regimen or a regimen of two full doses of AZD1222 or a comparator, 脑膜炎球菌结合疫苗称为MenACWY或生理盐水. The global trials are evaluating participants aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.
美国也在进行临床试验, 日本, 俄罗斯, 南非, 肯尼亚和拉丁美洲，并计划在其他欧洲和亚洲国家进行试验. 总的来说，公司预计将在全球招募多达6万名参与者.
The Company is making rapid progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, 待监管部门批准. 疫苗可以储存, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.
澳门葡京网赌游戏继续与政府接触, multilateral organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.
COV002
COV002是单盲试验, 的多中心, 随机, II/III期对照试验评估安全性, 12 . AZD1222的有效性和免疫原性,在英国有390名参与者. 到目前为止，试验参与者年龄在18岁或以上, who are healthy or have medically stable chronic diseases and are at increased risk for being exposed to the SARS-CoV-2 virus. 参与者接受一次或两次半剂量(~2)的肌肉注射剂量.5 x1010 病毒颗粒)或全剂量(~5x1010 病毒颗粒)的AZD1222或比较物，脑膜炎球菌疫苗MenACWY. Participants have blood samples drawn and clinical assessments for safety as well as immunogenicity at multiple timepoints up to one year post-vaccination. Suspected cases presenting with compatible symptoms were tested for virological confirmation by COVID-19 PCR. 除了, weekly swabbing are done for detection of infection and assessment of vaccine 功效 against infection.
COV003
COV003是单盲试验, 的多中心, 随机, 评估安全性的对照III期试验, 功效, AZD1222的免疫原性和免疫原性,300人参加巴西. 到目前为止，试验参与者年龄在18岁或以上, who are healthy or have medically stable chronic diseases and are at increased risk for being exposed to the SARS-CoV-2 virus. Participants are 随机 to receive two intramuscular doses of a full dose (~5x1010 病毒颗粒)的AZD1222或比较物, 脑膜炎球菌疫苗MenACWY作为第一剂，生理盐水安慰剂作为第二剂. Participants have blood samples drawn and clinical assessments for safety as well as immunogenicity at multiple timepoints up to one year post-vaccination. Suspected cases presenting with compatible symptoms were tested for virological confirmation by COVID-19 PCR.
AZD1222
AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. 接种疫苗后, 产生表面刺突蛋白, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
澳门葡京网赌游戏
澳门葡京网赌游戏(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门葡京赌博游戏公司，专注于发现, 处方药的开发和商业化, 主要用于治疗肿瘤等三个治疗领域的疾病, 心血管, 肾 & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门葡京网赌游戏 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 请访问 澳门葡京网赌游戏.com 并在推特 @上关注公司澳门葡京网赌游戏.
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