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。

看來招募成千上万的患者很重要

FDA 周二公布的指引表示,任何候选疫苗要获得批准,都必须要证明其比安慰剂的有效率高出至少50%,而且仅显示免疫反应数据还不够。

Porges 在给客户的信中写道:“很难预计这些研究如何招募成千上万的患者,给他们接种疫苗,然后观察他们六个月或更长时间的安全性,然后(在年底前)获得批准。”他说,一种完全批准的疫苗将需要“广泛的安全性数据和全面的临床疗效”。
 
这个Link有综合和追踪各个的研发中疫苗的进展状况

Screen Shot 2020-07-02 at 5.44.27 PM.png
 
看來招募成千上万的患者很重要

FDA 周二公布的指引表示,任何候选疫苗要获得批准,都必须要证明其比安慰剂的有效率高出至少50%,而且仅显示免疫反应数据还不够。

Porges 在给客户的信中写道:“很难预计这些研究如何招募成千上万的患者,给他们接种疫苗,然后观察他们六个月或更长时间的安全性,然后(在年底前)获得批准。”他说,一种完全批准的疫苗将需要“广泛的安全性数据和全面的临床疗效”。
疫苗不是药物。是要引起免疫反应。得过新冠的患者本身就可能已经有抗体产生。反而会干扰临床试验的结果。应该是招募健康人。
 
疫苗不是药物。是要引起免疫反应。得过新冠的患者本身就可能已经有抗体产生。反而会干扰临床试验的结果。应该是招募健康人。

以下是新浪财经的原文,没有 Porges 给客户的信的原文的链接,相信他们这里的 ”患者 ” 应该是指在疫区的可能接觸到感染的健康人吧:

Porges 在给客户的信中写道:“很难预计这些研究如何招募成千上万的患者,给他们接种疫苗,然后观察他们六个月或更长时间的安全性,然后(在年底前)获得批准。”他说,一种完全批准的疫苗将需要“广泛的安全性数据和全面的临床疗效”
 
“据该报道说,然而消息指出,将近一半的疫苗接种者出现不同副作用,其中46%发烧、44%疲劳、39%头痛,整体上有9%接种者因而出现活动受碍的现象,而相关专家亦对该疫苗的研究结果反应冷淡”

沒有副作用延續的時間和疫苗是否在軍中證明有效的消息
 
China’s CanSino in talks for COVID-19 vaccine Phase III trial overseas

ROXANNE LIU
REUTERS
PUBLISHED 3 HOURS AGO

Chinese vaccine developer CanSino Biologics is in talks with Russia, Brazil, Chile and Saudi Arabia to launch a Phase III trial of its experimental COVID-19 vaccine, its co-founder said on Saturday.

China’s success in driving down COVID-19 infections has made it harder to conduct large-scale vaccine trials, and so far only a few countries have agreed to work with it.

“We are contacting Russia, Brazil, Chile and Saudi Arabia (for the Phase III trial), and it’s still in discussion,” Qiu Dongxu, executive director and co-founder of CanSino, told an antiviral drug development conference in Suzhou, in eastern China.

He said its Phase III trial was likely to start “pretty soon,” and the company plans to recruit 40,000 participants for the test.

Its COVID-19 candidate, Ad5-nCov, became the first in China to move into human testing in March but is running behind other potential vaccines in terms of trial progress. Two experimental vaccines developed by Sinovac Biotech and a unit of China National Pharmaceutical Group (Sinopharm) are already approved for Phase III trials.

Qiu said its Phase II trial involving 508 people has yielded “much better” results than the Phase I about the safety and ability to trigger immune response. He did not disclose specific evidence.

He said its new factory under construction in China will allow it to produce 100-200 million doses of coronavirus vaccines per year by early 2021.

China’s military, whose research unit is co-developing the vaccine candidate, approved its military use last month, while Sinopharm’s two experimental shots are offered to employees at state-owned firms travelling overseas.

Zeng Guang, former chief epidemiologist at the Chinese Center for Disease Control and Prevention, told the conference that Chinese construction groups overseas in particular are keen to take experimental vaccines.

He also said discussion should start whether to launch emergency inoculation of experimental vaccines “right now.”

There are no approved vaccines yet for COVID-19, a respiratory disease caused by the new coronavirus, which has killed more than half a million people globally.







The Globe and Mail
 
07月11日 22:02
康希诺生物的执行董事兼联合创始人邱东旭11日在苏州的“2020中国抗病毒药物创新大会”上透露,该公司正在与俄罗斯、巴西、智利和沙特阿拉伯进行谈判,以启动其新冠病毒实验疫苗的III期试验。邱东旭说,其III期试验可能“很快”开始,该公司计划招募4万名参与者进行试验。(界面)

 
中国康希诺正在帮助俄罗斯,巴西等国家实施COVID-19疫苗三期测试

新世界newworld 2020-07-12 13:51:18

康希诺生物制药公司联合创始人周六表示,中国疫苗开发公司康希诺生物制药正在与俄罗斯、巴西、智利和沙特阿拉伯就启动COVID-19实验性疫苗III期试验进行合作。

中国在降低COVID-19感染方面取得的成功,很多看到中国取得成功的国家都同意与中国合作,一起加强抗疫的工作,让国家早日走出困境。

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康希诺生物制药公司执行董事兼联合创始人邱东旭在苏州举行的抗病毒药物开发会议上表示:“我们正在联系俄罗斯、巴西、智利和沙特阿拉伯(进行III期试验),目前仍在讨论中。”

他说,第三阶段的试验可能会“很快”开始,公司计划招募4万名参与者进行测试。

今年3月,其新冠肺炎候选疫苗Ad5-nCov成为中国首个进行人体试验的疫苗,但在试验进展方面落后于其他潜在疫苗。由科兴生物技术公司和中国医药集团(Sinopharm)旗下子公司开发的两种实验性疫苗已获批进行三期临床试验。

邱东旭说,在安全性和引发免疫反应的能力方面,涉及508人的二期试验取得了比一期“更好”的结果。

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他说,康希诺生物制药公司在中国新建的工厂可以使其到2021年初每年生产1亿至2亿剂冠状病毒疫苗。

上个月,中国军方批准了这种疫苗的军用用途,而国药控股的两种实验性疫苗则提供给出国工作的国有企业员工。中国军方的研究部门正在联合开发这种候选疫苗。

中国疾病预防控制中心前首席流行病学家曾光在会议上表示,海外的中国建筑集团尤其需要接种这种实验性疫苗,以保证海外员工的安全,因为想在国外的感染率是非常高的。

COVID-19是一种由新型冠状病毒引起的呼吸系统疾病,在全球已造成50多万人死亡。

 
美德疫苗的新消息

2020年7月13日

财经网站CNBC报导,在美国与德国的临床研究中,编号「BNT162b1」和「BNT162b2」新冠候选疫苗是至少四种疫苗中进展最大的。

两家公司本月稍早曾表示,BNT162b1展现对抗新冠病毒的潜力,且在早期临床试验对人体具有良好的耐受性;德国的临床数据预计在本月公布。

公司表示,若候选疫苗研究告捷,并取得查验登记,预计今年底可生产1亿剂疫苗,并在2021年前生产逾12亿剂;他们补充,如果获得查验登记,预期最快本月稍晚将展开涵盖3万人的大规模临床试验。
 
10 min ago
American company expects to start large US Covid-19 vaccine trial on July 27
From CNN's John Bonifield


Moderna headquarters in Cambridge, Massachusetts.

Moderna headquarters in Cambridge, Massachusetts. Blake Nissen/The Boston Globe/Getty Images

Moderna, an American biotech company, expects to start their largest study yet of its Covid-19 vaccine candidate on July 27, according to details released Tuesday on a government database that tracks clinical trials conducted around the world.

Here is how the vaccine trial will work:
  • For the phase three study, researchers plan to enroll 30,000 adult participants, including people whose locations or circumstances put them at high-risk of infection.
  • One group will be injected with 100 micrograms of the vaccine on day one and again on day 29. A second group will be injected with two doses of a placebo for comparison.
  • Fourteen days after the participants get their second dose, the researchers will be looking at whether they develop Covid-19.
  • The participants will be followed for two years after receiving their second dose.
The study will be conducted at 87 locations across the United States.

Remember: Moderna’s vaccine candidate is one of 23 in clinical trials around the world, according to the World Health Organization.

Moderna's Covid-19 vaccine candidate is expected to be the first in the United States to begin phase three trials.
 
Canadian trials began Monday for a prospective coronavirus vaccine. The randomized, partially blinded study, which was launched in Quebec City, does not involve animal products or live viruses like some traditional vaccine trials. Rather, it will test a plant-based product on 180 healthy people between the ages of 18 and 55.

But Dr. Bruce Clark, president and CEO of the biopharmaceutical company Medicago, cautioned against unrealistic expectations that his product — or any of the numerous vaccines in development globally — will bring the pandemic to a screeching halt.

"Whatever vaccine we get in this first round — unless it's a miracle — it's not going to be perfect," he said. "It's going to have to undergo development. It's going to take probably years to come up with an understanding of the right vaccine, the right approach. It's not the panacea. To assume that we can have, in 18 months, the solution to a pandemic that comes around once in a generation is naive."​
 
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