以前沒注意到的俄罗斯疫苗的消息：
俄期待今秋开始大规模接种新冠疫苗-新华网
俄期待今秋开始大规模接种新冠疫苗 ---俄罗斯副总理德米特里·切尔内申科2日说，俄罗斯有望今年秋天开始大规模接种新冠疫苗。
www.xinhuanet.com
全球领先疫苗，39支疫苗进入3期实验，10月13日，德国法国放弃两款mRNA疫苗，转为研发新一代疫苗和加强剂。中国两款疫苗进入第三期试验。
- 主题发起人 lindamy
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- 2005-11-23
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这个疫苗是中美合作的吗？
2 hr 23 min ago
Human trial begins in China on another potential Covid-19 antibody therapy
From CNN Health’s Jen Christensen
Doctors dosed a healthy volunteer on Monday with an antibody treatment developed by Eli Lilly and Chinese company Junshi Biosciences to fight Covid-19.
The trial is underway in China. Lilly will start a complementary Phase one study in the United States in the next few days, the company said.
Scientists will first test to see if this antibody treatment, called JS016, is safe to be used in humans. If so, it will be tested to see if it if effective.
If this first phase is successful, more trials will run to determine how to use it most effectively.
The companies will also experiment to see if the antibody could be used on its own or if it would be more effective used in combination with other antibody candidates. JS016 appeared to neutralize the virus in the lab. Lilly and Junshi scientists are testing other potential antibodies in the lab to see which work best.
This is the second such antibody therapy trial from the Indianapolis-based pharmaceutical company. Lilly is testing another antibody treatment called LY-COV555 that the company developed with AbCellera.
Junshi Biosciences is leading development in greater China, according to Lilly, and Eli Lilly has exclusive rights to it in the rest of the world.
There are several other companies trying to create antibody therapies to fight Covid-19, including Regeneron Pharmaceuticals, which has said it expects to begin clinical trials this month.
Some background: Antibodies are proteins your body makes in the thousands that naturally fight off infection. To make an antibody therapy, scientists have to sort through thousands of antibodies to determine which work best to neutralize a particular threat.
Typically, drug developers will pick one and then clone it until there are enough monoclonal antibodies to put in a medicine.
Antibody treatments are currently used to treat some cancers, eye problems, chronic and infectious disease. The treatments can be used to treat symptoms or potentially as a protective medicine to prevent infection in vulnerable populations like the elderly or in health care workers.
2 hr 23 min ago
Human trial begins in China on another potential Covid-19 antibody therapy
From CNN Health’s Jen Christensen
Doctors dosed a healthy volunteer on Monday with an antibody treatment developed by Eli Lilly and Chinese company Junshi Biosciences to fight Covid-19.
The trial is underway in China. Lilly will start a complementary Phase one study in the United States in the next few days, the company said.
Scientists will first test to see if this antibody treatment, called JS016, is safe to be used in humans. If so, it will be tested to see if it if effective.
If this first phase is successful, more trials will run to determine how to use it most effectively.
The companies will also experiment to see if the antibody could be used on its own or if it would be more effective used in combination with other antibody candidates. JS016 appeared to neutralize the virus in the lab. Lilly and Junshi scientists are testing other potential antibodies in the lab to see which work best.
This is the second such antibody therapy trial from the Indianapolis-based pharmaceutical company. Lilly is testing another antibody treatment called LY-COV555 that the company developed with AbCellera.
Junshi Biosciences is leading development in greater China, according to Lilly, and Eli Lilly has exclusive rights to it in the rest of the world.
There are several other companies trying to create antibody therapies to fight Covid-19, including Regeneron Pharmaceuticals, which has said it expects to begin clinical trials this month.
Some background: Antibodies are proteins your body makes in the thousands that naturally fight off infection. To make an antibody therapy, scientists have to sort through thousands of antibodies to determine which work best to neutralize a particular threat.
Typically, drug developers will pick one and then clone it until there are enough monoclonal antibodies to put in a medicine.
Antibody treatments are currently used to treat some cancers, eye problems, chronic and infectious disease. The treatments can be used to treat symptoms or potentially as a protective medicine to prevent infection in vulnerable populations like the elderly or in health care workers.
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位于温哥华的Algernon药品公司（Algernon Pharmaceuticals Inc.）在6月4日宣布，其有关NP-120的新冠病患试验研究，已经获得了美国食品药品监督管理局（FDA）批准。
这项研究此前已经在4月底通过了加拿大卫生部（Health Canada）的审批，也就是说在不久之后，其第二阶段的临床试验就将在加拿大和美国共同展开。
作为实验中的关键药物NP-120（Ifenprodil），其实是一种市面上已有的获批药品。它开发于1990年代，主要用于治疗心血管疾病，是已在日本上市20多年、有较长使用记录和被证明安全性的药物。
在去年底，一家中国科研团队《mSystems》发表论文，证实了NP-120对H5N1型流感病毒的作用。
Algernon公司分析认为NP-120能够通过抑制新冠患者的肺部白细胞浸润，从而防止细胞素风暴（cytokine storm）引起的肺功能丧失甚至死亡。也就是说，它极有可能成为治疗新冠病患的有效药物，此外还可能降低患者的发病率。
这项研究于今年3月初开始计划，由于NP-120是已知安全的上市药物，因此大大缩短了试验时间，省去了额外的临床前测试步骤，可以在申请通过之后，安全地给参与试验的患者服用。
在即将开始的第二阶段实验中，会有加拿大和美国的100名中度及重症新冠患者参与，一半患者将在三周内每天服用两次NP-120药物，与另一半不服用NP-120进行普通治疗的病患进行对比。
比较数据包括死亡率、血氧水平、在重症治疗室ICU的时长和用呼吸机的时长等。
如果第二阶段的试验结果理想，Algernon公司预计在9月份开始纳入更多患者的第三阶段试验；如果以上试验都取得成功，这种药物将有希望在2021年的头三个月之内作为抗新冠药物上市。
此前加拿大与中国康希诺生物合作研究的Ad5-nCoV疫苗也有重大突破，在试验对象接种28天后都产生了免疫反应；
这种Ad5-nCoV疫苗是第一个被加拿大卫生局批准进入人体临床试验步骤的，也是全球实验进度最快的新冠疫苗之一，可以说相当给力了！
希望能够对抗新冠病毒药物和疫苗尽快早日取得所有试验成功，尽快研究出来造福人类！
6月16日，国药中国生物武汉生物制品研究所研制的新冠病毒灭活疫苗Ⅰ/Ⅱ期临床试验盲态审核暨阶段性揭盲会在北京、河南两地同步举行。国务院联防联控机制疫苗专班、国家科技部生物技术发展中心有关专家出席。
揭盲结果显示：疫苗接种后安全性好，无一例严重不良反应，不同程序、不同剂量接种后，疫苗组接种者均产生高滴度抗体，0,28天程序接种两剂后，中和抗体阳转率达100%。
...
与此同时，中国生物积极推进Ⅲ期临床的海外合作，与多个国家的企业及机构确定了合作意向。中国生物已率先建成了高生物安全等级生产车间，这也是目前全球唯一符合生物安全和GMP标准、从数量上能够满足紧急接种需求的新冠疫苗生产车间。
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1 hr 9 min ago
Pharmaceutical company begins phase 3 trial of arthritis drug for Covid-19 patients
From CNN's Jen Christensen
Eli Lilly & Co. corporate headquarters stand in Indianapolis on May 21, 2012. Victor J. Blue/Bloomberg/Getty Images
The first patient in a phase 3 trial was dosed with a drug from Eli Lilly that the pharmaceutical company hopes can help hospitalized patients with Covid-19.
The drug — named baricitinib and marketed as Olumiant — is a therapy approved to treat adults that have moderate to severe active rheumatoid arthritis.
The phase 3 study will enroll 400 patients with Covid-19 who have at least one marker for inflammation but have not been put on a ventilator by the start of the study. The study looks at whether the drug could reduce cytokine storm, the body’s hyper-inflammatory response to the virus and a severe complication that can come with Covid-19 infection.
About the trial: The trial will be conducted in the United States, Latin America and Europe. Lilly said the company should know how well the therapy works in a couple of months.
This is a randomized, double-blind, placebo-controlled trial. Patients will get standard care or they will be treated with baricitinib for 14 days or until they are discharged from the hospital. The study will measure if someone improves, if they are put on a ventilator by day 28, or if they die.
The drug is also being used in a few other trials with Covid-19 patients. In one trial by the National Institute of Allergy and Infectious Diseases, scientists are trialing the drug in combination with Gilead’s antiviral remdesivir.
Pharmaceutical company begins phase 3 trial of arthritis drug for Covid-19 patients
From CNN's Jen Christensen
Eli Lilly & Co. corporate headquarters stand in Indianapolis on May 21, 2012. Victor J. Blue/Bloomberg/Getty Images
The first patient in a phase 3 trial was dosed with a drug from Eli Lilly that the pharmaceutical company hopes can help hospitalized patients with Covid-19.
The drug — named baricitinib and marketed as Olumiant — is a therapy approved to treat adults that have moderate to severe active rheumatoid arthritis.
The phase 3 study will enroll 400 patients with Covid-19 who have at least one marker for inflammation but have not been put on a ventilator by the start of the study. The study looks at whether the drug could reduce cytokine storm, the body’s hyper-inflammatory response to the virus and a severe complication that can come with Covid-19 infection.
About the trial: The trial will be conducted in the United States, Latin America and Europe. Lilly said the company should know how well the therapy works in a couple of months.
This is a randomized, double-blind, placebo-controlled trial. Patients will get standard care or they will be treated with baricitinib for 14 days or until they are discharged from the hospital. The study will measure if someone improves, if they are put on a ventilator by day 28, or if they die.
The drug is also being used in a few other trials with Covid-19 patients. In one trial by the National Institute of Allergy and Infectious Diseases, scientists are trialing the drug in combination with Gilead’s antiviral remdesivir.
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6 hr 13 min ago
Human trials expected to start next month for Covid-19 treatment derived from cows' blood
From CNN's Elizabeth Cohen
A South Dakota company expects to start human trials next month for a Covid-19 antibody treatment derived from the plasma of cows.
But these aren't just any cows. Scientists genetically engineered the animals to give them an immune system that's part human. That way, the animals produce disease-fighting human antibodies to Covid-19, which are then turned into a drug to attack the virus.
Read more on how it's done:
RELATED
Human trials expected to start next month for Covid-19 treatment derived from cows' blood
Human trials expected to start next month for Covid-19 treatment derived from cows' blood
From CNN's Elizabeth Cohen
A South Dakota company expects to start human trials next month for a Covid-19 antibody treatment derived from the plasma of cows.
But these aren't just any cows. Scientists genetically engineered the animals to give them an immune system that's part human. That way, the animals produce disease-fighting human antibodies to Covid-19, which are then turned into a drug to attack the virus.
The company did not say how many people would be studied in the clinical trials or how long they would take.
Read more on how it's done:
RELATED
Human trials expected to start next month for Covid-19 treatment derived from cows' blood
又一陈薇团队的消息：
2020-06-24 12:39:07
据《解放军报》消息，中国科学家在新型冠状病毒抗体研究中取得重大突破。由中国工程院院士、军事科学院军事医学研究院研究员陈薇领衔的团队，发现了首个靶向刺突蛋白N端结构域的高效中和单克隆抗体。北京时间6月22日22:00，国际顶级学术期刊《科学》在线发表了该项研究结果。这也是陈薇团队研发的腺病毒载体重组新冠疫苗在全球率先进入Ⅱ期临床试验后，取得的又一项世界级科研成果。
2020-06-24 12:39:07
陈薇团队：新冠病毒抗体研究取得重大突破--万维读者网
据《解放军报》消息，中国科学家在新型冠状病毒抗体研究中取得重大突破。由中国工程院院士、军事科学院军事医学研究院研究员陈薇领衔的团队，发现了首个靶向刺突蛋白N端结构域的高效中和单克隆抗体。北京时间6月22日22:00，国际顶级学术期刊《科学》在线发表
news.creaders.net
据《解放军报》消息，中国科学家在新型冠状病毒抗体研究中取得重大突破。由中国工程院院士、军事科学院军事医学研究院研究员陈薇领衔的团队，发现了首个靶向刺突蛋白N端结构域的高效中和单克隆抗体。北京时间6月22日22:00，国际顶级学术期刊《科学》在线发表了该项研究结果。这也是陈薇团队研发的腺病毒载体重组新冠疫苗在全球率先进入Ⅱ期临床试验后，取得的又一项世界级科研成果。
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那么多好说关心加拿大，关心中加友好关系的，怎么从来没见来关心一下这个处于世界领先地位的中加合作疫苗进展？关心都是怎么体现的？又一陈薇团队的消息：
2020-06-24 12:39:07
陈薇团队：新冠病毒抗体研究取得重大突破--万维读者网
据《解放军报》消息，中国科学家在新型冠状病毒抗体研究中取得重大突破。由中国工程院院士、军事科学院军事医学研究院研究员陈薇领衔的团队，发现了首个靶向刺突蛋白N端结构域的高效中和单克隆抗体。北京时间6月22日22:00，国际顶级学术期刊《科学》在线发表news.creaders.net
据《解放军报》消息，中国科学家在新型冠状病毒抗体研究中取得重大突破。由中国工程院院士、军事科学院军事医学研究院研究员陈薇领衔的团队，发现了首个靶向刺突蛋白N端结构域的高效中和单克隆抗体。北京时间6月22日22:00，国际顶级学术期刊《科学》在线发表了该项研究结果。这也是陈薇团队研发的腺病毒载体重组新冠疫苗在全球率先进入Ⅱ期临床试验后，取得的又一项世界级科研成果。
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全球逾百疫苗研发中 一文掌握各国药厂进度
文章来源: 苹果日报 于 2020-06-29 13:42:13 - 新闻取自各大新闻媒体，新闻内容并不代表本网立场！
(被阅读 723 次)
美联社
全球目前有超过100款疫苗正处于研发及测试阶段，当中只有少部份正进行人体临床试验，以下是一些已开始或计划展开疫苗临床试验的大型药厂及研究所。
美国药厂娇生（Johnson & Johnson）
药厂提前两个月在7月下旬，就疫苗展开人体临床试验，并会在美国及比利时做临床试验。
美国生物科技公司莫德纳公司（Moderna Inc.）
莫德纳盼加快完成两条商业生产线，并计划在7月开始后期试验。
美国生物科技公司「Inovio Pharmaceutical」
疫苗正处于初期测试阶段，预计在6月公佈人体试验结果。
德国生物技术公司「BioNTech SE」
目前进入人体试验的初期至中期阶段，公司与美国辉瑞公司（PfizerInc.）合作，在2020年底前製造1,000万至2,000万剂实验疫苗。
德国生物科技公司「CureVac」
已展开初期人体实验，期望在9月或10月获得实验数据，计划疫苗在2021年中获得批准。
英国药厂葛兰素史克（GlaxoSmithKline）
葛兰素史克联同赛诺菲（Sanofi）研发疫苗，料于今年下半年开展初期临床试验。
英国伦敦帝国学院（Imperial College London）
研究团队上周安排300名志愿人士参与首阶段疫苗临床试验，预计在10月进行第二次试验，届时会有6,000人测试。
南韩药厂「Genexine Inc」
已开展首阶段人体临床实验。
泰国研究团队
研究团队正安排猴子进行疫苗研究，如果进展顺利，最快10月会利用1万剂进行人体试验，团队成员之一、朱拉隆功大学疫苗研究和发展中心主任鲁桑龙探（Kiat Ruxrungtham）表示，如果研发过程顺利，疫苗在明年中或下旬就可以量产。（国际中心／综合外电报导）
文章来源: 苹果日报 于 2020-06-29 13:42:13 - 新闻取自各大新闻媒体，新闻内容并不代表本网立场！
(被阅读 723 次)
美联社
全球目前有超过100款疫苗正处于研发及测试阶段，当中只有少部份正进行人体临床试验，以下是一些已开始或计划展开疫苗临床试验的大型药厂及研究所。
美国药厂娇生（Johnson & Johnson）
药厂提前两个月在7月下旬，就疫苗展开人体临床试验，并会在美国及比利时做临床试验。
美国生物科技公司莫德纳公司（Moderna Inc.）
莫德纳盼加快完成两条商业生产线，并计划在7月开始后期试验。
美国生物科技公司「Inovio Pharmaceutical」
疫苗正处于初期测试阶段，预计在6月公佈人体试验结果。
德国生物技术公司「BioNTech SE」
目前进入人体试验的初期至中期阶段，公司与美国辉瑞公司（PfizerInc.）合作，在2020年底前製造1,000万至2,000万剂实验疫苗。
德国生物科技公司「CureVac」
已展开初期人体实验，期望在9月或10月获得实验数据，计划疫苗在2021年中获得批准。
英国药厂葛兰素史克（GlaxoSmithKline）
葛兰素史克联同赛诺菲（Sanofi）研发疫苗，料于今年下半年开展初期临床试验。
英国伦敦帝国学院（Imperial College London）
研究团队上周安排300名志愿人士参与首阶段疫苗临床试验，预计在10月进行第二次试验，届时会有6,000人测试。
南韩药厂「Genexine Inc」
已开展首阶段人体临床实验。
泰国研究团队
研究团队正安排猴子进行疫苗研究，如果进展顺利，最快10月会利用1万剂进行人体试验，团队成员之一、朱拉隆功大学疫苗研究和发展中心主任鲁桑龙探（Kiat Ruxrungtham）表示，如果研发过程顺利，疫苗在明年中或下旬就可以量产。（国际中心／综合外电报导）
- 注册
- 2005-11-23
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3 hr 23 min ago
Scientist leading Oxford vaccine effort says 8,000 people in UK vaccinated in phase three of the trial
From CNN's Jo Shelley in London
Eight thousand people in the UK have been vaccinated so far as part of the Oxford University vaccine trial, Sarah Gilbert, professor of vaccinology at the University of Oxford, and one of the scientist leading its vaccine initiative, told UK’s Science and Technology Committee on Wednesday.
“We now have 8,000 people vaccinated in the phase three trial in the UK,” she said.
“We have currently vaccinated a few hundred people in Brazil but within weeks that should be up to 4,000. And in South Africa, we are aiming for 2,000 people. And those are both areas of high transmission at the moment,” Gilbert added.
Sir John Bell, Regius professor of medicine at the University of Oxford, who is also working on the development of Covid-19 vaccine, was asked whether the UK should prepare for a winter without a vaccine.
He told the committee: “This whole epidemic has relied too heavily on assumptions that have turned out not to be true, so my strong advice is, be prepared for the worst.”
Scientist leading Oxford vaccine effort says 8,000 people in UK vaccinated in phase three of the trial
From CNN's Jo Shelley in London
Eight thousand people in the UK have been vaccinated so far as part of the Oxford University vaccine trial, Sarah Gilbert, professor of vaccinology at the University of Oxford, and one of the scientist leading its vaccine initiative, told UK’s Science and Technology Committee on Wednesday.
“We now have 8,000 people vaccinated in the phase three trial in the UK,” she said.
“We have currently vaccinated a few hundred people in Brazil but within weeks that should be up to 4,000. And in South Africa, we are aiming for 2,000 people. And those are both areas of high transmission at the moment,” Gilbert added.
Sir John Bell, Regius professor of medicine at the University of Oxford, who is also working on the development of Covid-19 vaccine, was asked whether the UK should prepare for a winter without a vaccine.
He told the committee: “This whole epidemic has relied too heavily on assumptions that have turned out not to be true, so my strong advice is, be prepared for the worst.”
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- 2005-11-23
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6 hr 33 min ago
Covid-19 vaccine from Pfizer and BioNTech shows "encouraging" data in early study
From CNN Health's Jacqueline Howard
The Covid-19 vaccine candidate being developed by US pharmaceutical company Pfizer and German biotechnology company BioNTech has yielded positive data in early tests, according to data released by the companies.
The companies announced these preliminary findings on Wednesday in a pre-print paper that shows participants in a Phase 1/2 study of the vaccine, called BNT162b1, responded to the immunization and it was found to be well tolerated. The Phase 1/2 study is ongoing. The data has not yet been published in a peer-reviewed medical journal.
Twelve participants received two 10 microgram doses 21 days apart; 12 received two 30 microgram doses 21 days apart; 12 received a single 100 microgram dose on day one; and nine received placebo, according to the study.
In the seven days following injection of the vaccine, some participants who received a dose reported pain in the injection site, fever or sleep disturbances, but "no serious adverse events were reported," according to the paper.
Early results of the study: The researchers found that the vaccine generated antibodies against the coronavirus in all of the participants by 28 days after receiving a single injection of 100 micrograms or seven days after receiving a second dose of either 10 or 30 micrograms.
"These preliminary data are encouraging, showing that BNT162b1 which exploits RBD SARS-CoV-2 as a target antigen is able to produce neutralizing antibody responses in humans at or above the levels observed in convalescent sera – and that it does so at relatively low dose levels. We look forward to providing further data updates on BNT162b1," Dr. Ugur Sahin, CEO and co-founder of BioNTech, said in a company press release on Wednesday.
Pfizer and BioNTech announced on Wednesday that this preliminary data will help them determine a dose level for the vaccine then select which of their multiple vaccine candidates to progress to a larger-scale global Phase 2/3 study, possibly beginning as early as this month.
According to the World Health Organization, there are 17 coronavirus candidate vaccines in clinical evaluation globally.
Covid-19 vaccine from Pfizer and BioNTech shows "encouraging" data in early study
From CNN Health's Jacqueline Howard
The Covid-19 vaccine candidate being developed by US pharmaceutical company Pfizer and German biotechnology company BioNTech has yielded positive data in early tests, according to data released by the companies.
The companies announced these preliminary findings on Wednesday in a pre-print paper that shows participants in a Phase 1/2 study of the vaccine, called BNT162b1, responded to the immunization and it was found to be well tolerated. The Phase 1/2 study is ongoing. The data has not yet been published in a peer-reviewed medical journal.
How the study was conducted: For the initial study, 45 participants ages 18 to 55 were randomly assigned to either receive a certain dose of the vaccine or placebo.
Twelve participants received two 10 microgram doses 21 days apart; 12 received two 30 microgram doses 21 days apart; 12 received a single 100 microgram dose on day one; and nine received placebo, according to the study.
In the seven days following injection of the vaccine, some participants who received a dose reported pain in the injection site, fever or sleep disturbances, but "no serious adverse events were reported," according to the paper.
Early results of the study: The researchers found that the vaccine generated antibodies against the coronavirus in all of the participants by 28 days after receiving a single injection of 100 micrograms or seven days after receiving a second dose of either 10 or 30 micrograms.
"These preliminary data are encouraging, showing that BNT162b1 which exploits RBD SARS-CoV-2 as a target antigen is able to produce neutralizing antibody responses in humans at or above the levels observed in convalescent sera – and that it does so at relatively low dose levels. We look forward to providing further data updates on BNT162b1," Dr. Ugur Sahin, CEO and co-founder of BioNTech, said in a company press release on Wednesday.
Pfizer and BioNTech announced on Wednesday that this preliminary data will help them determine a dose level for the vaccine then select which of their multiple vaccine candidates to progress to a larger-scale global Phase 2/3 study, possibly beginning as early as this month.
According to the World Health Organization, there are 17 coronavirus candidate vaccines in clinical evaluation globally.
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