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。


2020年12月1日外交部发言人华春莹主持例行记者会。路透社记者:一名美国分析人士援引日本情报称,中方向朝鲜领导人金正恩及其家人提供了实验性新冠肺炎疫苗。你能否证实?如属实,能否提供更多细节?

华春莹表示,我不知道这一消息从何而来,我没有听说。中国已有多支疫苗进入Ⅲ期临床实验,我们也已承诺疫苗研发完成并投入使用后将作为全球公共产品,积极考虑向发展中国家提供。我们将积极履行这一承诺。这是我们总的原则态度。
 
我们这里估计少说要等半年以后。
我预测明年下半年开始打,我问了一个医生朋友,他说乐观的话明年年初到春天开始打,但是量很少,而且只对特殊人群。
 
我预测明年下半年开始打,我问了一个医生朋友,他说乐观的话明年年初到春天开始打,但是量很少,而且只对特殊人群。
美国一般人群基本也要等到6月以后。
 
辉瑞疫苗今天在英国获得紧急使用许可了


 
1 hr 44 min ago

There's a lot of news about coronavirus vaccines today. Here's what you need to know.​

Researchers across the world have been working throughout the pandemic to develop, approve and distribute a coronavirus vaccine.

There's a lot of news about vaccines in Europe and in the US to catch up on this morning. If you're just reading in now, here's what you need to know:
  • The UK has approved a vaccine: The United Kingdom has become the first Western nation to approve a Covid-19 vaccine, a landmark moment in the coronavirus pandemic that paves the way for the first doses to be rolled out across the country next week. Elderly people in care homes, along with health workers and other vulnerable people, will be top of the priority list for those who get the vaccine first.
  • The US lays out a plan on who to vaccinate first: US Centers for Disease Control and Prevention advisers recommended yesterday that health care staff and long-term care facility residents be first in line for any Covid-19 vaccines that get emergency authorization in the country. Remember: The US Food and Drug Administration has not yet authorized any coronavirus vaccine candidate.
  • The vaccine timeline in the US: The FDA's Vaccines and Related Biological Products Advisory Committee, a panel of independent experts, will meet on Dec. 10 to review Pfizer's coronavirus vaccine candidate and make a recommendation about whether to authorize the vaccine. FDA officials say their decisions on the vaccines could come days to weeks after the meetings — it depends on what questions come up. A similar FDA committee meeting for Moderna's vaccine candidate is set for Dec. 17. The first shipments of Pfizer's vaccine in the US will be delivered on Dec. 15, according to an Operation Warp Speed document.
 
辉瑞疫苗今天在英国获得紧急使用许可了


20 min ago

The UK has granted temporary approval for Pfizer and BioNTech's Covid-19 vaccine​

From CNN's Claudia Otto and Fred Pleitgen

A handout photo provided by Pfizer shows their vaccine vials.
A handout photo provided by Pfizer shows their vaccine vials. Pfizer

Britain has become the first country to allow the use of Pfizer and its German partner BioNTech's Covid-19 vaccine after it was granted temporary authorization for emergency use, the companies announced.

This marks the first time that citizens outside of the worldwide clinical trials will have the opportunity to be immunized against Covid-19, according to BioNTech CEO Ugur Sahin.

Pfizer and BioNTech previously said that analysis of the vaccine showed it was 95% effective with no safety concerns.

The vaccine will be made available across the UK starting next week, said a spokesperson from the Department of Health and Social Care in a statement. More details will be released soon, including advice for priority groups like the elderly and health care staff to receive the vaccine.

“To aid the success of the vaccination programme it is vital everyone continues to play their part and abide by the necessary restrictions in their area so we can further suppress the virus and allow the NHS to do its work without being overwhelmed," the spokesperson said.

In a news release, Pfizer CEO Albert Bourla hailed the emergency authorization as "a historic moment in the fight against COVID-19."
"This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the (Medicines & Healthcare Products Regulatory Agency) for their ability to conduct a careful assessment and take timely action to help protect the people of the UK," he said.

Sahin added that the regulatory data was the result of "a scientifically rigorous and highly ethical research and development program."

The companies had previously signed an agreement to supply 40 million doses to the UK with delivery in 2020 and 2021.
 
8 hr 22 min ago

Former US presidents volunteer to take coronavirus vaccine publicly to prove it's safe​

From CNN’s Jamie Gangel
From left to right, former presidents Barack Obama, George W. Bush and Bill Clinton attend the opening ceremony of the George W. Bush Presidential Center in Dallas, Texas, on April 25, 2013.
From left to right, former presidents Barack Obama, George W. Bush and Bill Clinton attend the opening ceremony of the George W. Bush Presidential Center in Dallas, Texas, on April 25, 2013. Alex Wong/Getty Images

Three former United States presidents -- Barack Obama, George W. Bush and Bill Clinton -- are volunteering to receive their Covid-19 vaccines on camera in order to promote public confidence in the medication's safety.

The three former presidents hope an awareness campaign to promote confidence in the vaccine's safety and effectiveness would be a powerful message as American public health officials try to convince the public to get vaccinated once the US Food and Drug Administration authorizes one.
Freddy Ford, Bush's chief of staff, told CNN that the 43rd president had reached out to Dr. Anthony Fauci -- the director of the National Institute of Allergy and Infectious Diseases -- and Dr. Deborah Birx, the White House coronavirus response coordinator, to see how he could help promote the vaccine.

"A few weeks ago President Bush asked me to let Dr. Fauci and Dr. Birx know that, when the time is right, he wants to do what he can to help encourage his fellow citizens to get vaccinated," Ford told CNN. "First, the vaccines need to be deemed safe and administered to the priority populations. Then, President Bush will get in line for his, and will gladly do so on camera."

Clinton's press secretary told CNN on Wednesday that he too would be willing to take the vaccine in a public setting in order to promote it.

"President Clinton will definitely take a vaccine as soon as available to him, based on the priorities determined by public health officials. And he will do it in a public setting if it will help urge all Americans to do the same," Angel Urena said.

It has been previously reported that Obama said in an interview with SiriusXM host Joe Madison, scheduled to air Thursday, that if Fauci said a coronavirus vaccine is safe, he believes him.
 
静等他们三个有药厂股份的“news”。。。。
 

比比几款新冠疫苗的优缺点​

Original 阿司匹林42195 阿司匹林42195米 6 days ago
from WeChat

十秒钟总结:
  1. 辉瑞疫苗(Pfizer/BioNTech):最先上市
  2. 莫德纳疫苗(Moderna):主打美国
  3. 阿斯利康/牛津大学疫苗(AstroZeneca/Oxford):价廉量大

上面是目前已宣布3期临床试验结果的疫苗,这篇会从疫苗的技术、有效性、安全性、定价、发放途径、以及上市日期六个方面比较一下,它们各自有什么优缺点?

一,疫苗研发技术

辉瑞和莫德纳都是信使RNA(mRNA)疫苗,代表了疫苗研发的最新技术。阿斯利康是腺病毒疫苗,科学家已经用这个方法成功研发出埃博拉疫苗。这两类疫苗都用了病毒表面蛋白的基因片段,没有繁殖基因,所以不会对人体造成感染风险。

目前发现新冠病毒不像流感病毒那样容易变异,所以不担心病毒变异造成疫苗失效的问题。

二,疫苗的效果如何?

目前看来,这三种疫苗都对新冠病毒有保护效果,尤其辉瑞和莫德纳的信使RNA疫苗令人喜出望外。

  1. 辉瑞是全球唯一完成3期试验的疫苗,结果显示95%有效。
  2. 莫德纳的中期分析显示94.5%有效。
  3. 牛津的疫苗刚刚宣布中期分析结果,62%-90%有效。
    1. 近1/4的人第一剂疫苗(因为计算错误!)只打了一半的剂量,结果这批人反而显示90%有效。
    2. 但是这批人比较年轻,没有55岁以上的,所以是不是年轻人更容易产生强烈的免疫反应?尚不详,可能要加试验。

疫苗试验是events-driven(病人数驱动),就是说什么时候各试点汇总的新冠病人达到预定数目,什么时候出结果,无法人为控制。

那些以为药厂故意卡在大选后出结果的朋友,警惕性过高了。

又有人觉得辉瑞从中期分析到完成3期试验“太快”,怕有猫腻。

其实,是欧美疫情的再次爆发,导致病人激增,很快达到试验终点。

要注意的是,目前只有新闻报道,疫苗的效果到底怎样,还需要等药品管理部门仔细评估具体数据。

三,这些疫苗安全吗?

这三个疫苗试验都没发现有重大安全问题。

辉瑞和莫德纳疫苗最常见的副作用是注射部位疼痛、头疼和疲劳,比一般流感疫苗反应严重些。

不过世界上还没有过一款上市的信使RNA疫苗,所以其长期安全性还在不断的观察和评估中。

四,疫苗如何发放?

疫苗在冰箱里(2-8°C)的保存时间:
  • 辉瑞:5天
  • 莫德纳:1个月
  • 阿斯利康:6个月

辉瑞和莫德纳的信使RNA疫苗都很娇弱,必须冷冻保存。尤其是辉瑞疫苗,必须在94F(-70°C)条件下存放。

不过辉瑞说了,他们有办法:

  • 辉瑞一直是用一种冷冻箱给150个临床试验点送疫苗,每只箱子像手提皮箱那么大,可以装1000剂疫苗。
  • 只要定期补充干冰,这个箱子可以在-70°C左右保持10天。
  • 每个箱子都有温度计和GPS,这样总部可以一直跟踪每个箱子的温度和位置。
而Moderna的疫苗只要储存在-20°C,一般冰柜都能达到这个温度。

阿斯利康疫苗最好,保存在普通冰箱里即可,所以在发展中国家的分发会更容易。

五,价格如何?

政府批量购买的每剂平均价格:
  • 辉瑞:20美元
  • 莫德纳:35美元
  • 阿斯利康:3.5美元

阿斯利康承诺在疫情期间不赚钱,只收成本价,让世界各地的人都负担得起。

有人惊呼,阿斯利康疫苗比一杯咖啡还便宜!

在美国,新冠疫苗是免费的,但个人可能要交打针费。

六,大众最关心的是,我们啥时能打上?

2020年底可生产出的剂量:
  • 辉瑞:5000万(其中2000万给美国)
  • 莫德纳:2000万(都给美国)
  • 阿斯利康:2亿(给英国和世界)

这次疫情非同寻常,有的国家下了很大的赌注:一边研发一边大量生产疫苗。所以疫苗一旦显示有效,马上就有一批可以送往抗疫前线。

莫德纳和阿斯利康的疫苗分别是美国和英国政府斥资的,辉瑞则是自己掏钱研发,但美国政府有购买担保。

目前的先行者是辉瑞疫苗。

辉瑞已于11月20号向美国FDA递交了紧急使用的申请,据说这种申请常常是几百上千页资料,专家正在审阅中。

FDA会在12月10日召开“疫苗顾问委员会”的会议,听取专家们对辉瑞疫苗的看法。这个会议和上次提过的疫苗讨论会一样,网上全程公开,任何人都可以旁观。

11月27日新闻,辉瑞已经包了美联航的专机,准备从布鲁塞尔运疫苗到芝加哥:

一旦FDA批准,有六百四十万辉瑞疫苗可以立刻提供给一线医护人员。不过,因为这个疫苗对储存的要求比较高,各地可能需要一段时间才能适应整个运输储存使用的流程。

美国第一批打上疫苗的会是医务人员和接受长期护理的病人,每人两剂预计共需四千八百万剂疫苗。

批量生产之王是阿斯利康疫苗。

生产腺病毒疫苗比生产信使RNA疫苗容易,阿斯利康已经和世界最大的疫苗生产基地-“印度血清研究所”-签署了生产10亿剂疫苗的协议。

阿斯利康预计明年可能生产30亿剂,可以让全球近1/5的人打上。

现在对大众何时能打上疫苗有各种传说,有些公众号误传美国会“明年四月前全部接种完毕”,作者可能不了解两针疫苗之间需隔3到4周才能打完。

最准确的信息来自美国疾控中心CDC,因为这个机构负责疫苗使用的规划和发放。

目前CDC明确指出:到2021年的下半年,所有的成年人应该可以得到疫苗。但儿童什么时候能打上疫苗还需要更多的临床试验。
另外,目前科学界认为打完第二针新冠疫苗的1至2周后,人体才能产生足够的抗体,所以计划明年出门玩耍的朋友要算好日期哈。

对比三种疫苗的优缺点,这张图总结得很好:

中国研发的疫苗目前正在巴西、阿根廷等国做3期临床试验,估计很快就会传出好消息。

疫情可能在地球上的任何地点爆发。比尔盖茨一直提醒大家,对于新冠这种严重的传染病,只有让各国的人都打上疫苗,才是全世界快速终结疫情的最大希望

 

卫生部关于英国批准辉瑞COVID-19疫苗的声明​


加拿大联邦卫生部知悉英国药品和医疗产品监管局已发布临时授权,批准临时有限供应该国第一款由辉瑞/ BioNTech 公司制造的 COVID-19 疫苗。
加拿大卫生部对这种疫苗的独立审查正在进行,并有望很快完成。
卫生部正在与包括英国在内的国际监管机构紧密合作,共享目前正在审核之疫苗的信息和数据。只有在完成评估其安全性、功效和质量的独立审查程序后,才能批准疫苗在加拿大使用。
从 2020 年 10 月 3 日起,这款疫苗已依照加拿大卫生部《关于进口、销售和广告与COVID-19 相关药物的临时指令》接受审核。这使加拿大卫生部可以持续审查制造商提交的数据,而不必等待收集完所有数据然后一次性提交。
尽管这是一个加急的审批流程,但只有满足加拿大卫生部严格的安全性、功效和质量要求的疫苗才可获得批准。
 
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