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。

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印度Bharat Biotech 的灭活疫苗新近进入第3期试验。

In 1996, Dr. Krishna M. Ella & Mrs. Suchitra Ella start Bharat Biotech in Genome Valley, Hyderabad, India—the first company to set up operations in the biotechnology park.

https://www.bharatbiotech.com/
 
最后编辑:

Putin Says India, China May Start Producing Russia's Sputnik V COVID-19 Vaccine​

nurse wears gloves with a bottle of the vaccine placed nearby
A nurse prepares to inoculate a volunteer with Russia's new coronavirus vaccine in a post-registration trial in Moscow on September 10, 2020. (Natalia Kolesnikova/Getty Images)
Tuesday, 17 Nov 2020 6:50 AM

 
美国辉瑞疫苗正在研究可在室温下运输的疫苗配方。

32 min ago

BioNTech is working on a vaccine formula that can be shipped at room temperature​

From CNN’s Frederik Pleitgen, Claudia Otto and Vasco Cotovio


BioNTech CEO Uğur Şahin speaks with CNN on Wednesday, November 18.
BioNTech CEO Uğur Şahin speaks with CNN on Wednesday, November 18. CNN

The German biotech company BioNTech is working on a formula for its vaccine that would allow it to be shipped at room temperature, CEO Uğur Şahin told CNN’s Frederik Pleitgen in an exclusive interview on Wednesday.

“We are working on formulation which could allow us to ship the vaccine even maybe at room temperature and this type of development is happening in parallel,” Sahin said.

Concerns were raised that it would be difficult to distribute the vaccine BioNTech is working on with US pharmaceutical giant Pfizer because it needs to be stored at about minus 75 degrees Celsius, which is about 50 degrees colder than any vaccine currently used in the United States.

Doctors' offices, pharmacies and state labs don't have freezers that go nearly that low but Sahin is now saying that is a temporary issue.

“Since the development was so fast, we were not able to work out better, more stable conditions,” he said. “We believe that in the second half of 2020 we will have come up with a formulation which is comparable to any other type of vaccine.”
 
48 min ago

Almost a million people have been given an experimental Chinese coronavirus vaccine, pharma giant claims​

From CNN's Ben Westcott and Sophie Jeong

Almost a million people have been given an experimental coronavirus vaccine developed by Sinopharm as part of an emergency-use program authorized by Beijing, the Chinese pharmaceutical giant's chairman said.

No serious adverse effects have been reported from vaccine recipients so far, Sinopharm said Wednesday in an article on social media platform WeChat, citing Chairman Liu Jingzhen.

"In emergency use, we now have used it on nearly a million people. We have not received any reports of serious adverse reaction, and only a few have some mild symptoms," Liu said.

Liu said the vaccine had been given to Chinese construction workers, diplomats, and students who have gone to more than 150 countries during the pandemic -- and none of them has reported an infection.

He said on November 6 that there were 56,000 people who had received emergency vaccinations and then gone overseas.

"For example, a transnational company has 99 employees in one of its overseas offices, of whom 81 were vaccinated. And later, an outbreak broke out in the office, 10 of the 18 people who were not vaccinated were infected and none of those vaccinated were infected," he said.

Read the full story:
Almost a million people have been given an experimental Chinese coronavirus vaccine
RELATED

Almost a million people have been given an experimental Chinese coronavirus vaccine

 
1 hr 45 min ago

US vaccine chief says first Americans could be vaccinated on Dec. 11​

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Dr. Moncef Slaoui, the head of the government's effort to develop a vaccine against Covid-19, said the first Americans to receive a coronavirus vaccine could get it as soon as Dec. 11.

On Friday, Pfizer submitted an application to the US Food and Drug Administration for emergency use authorization for their Covid-19 vaccine candidate, and an FDA vaccine advisory committee is slated to meet December 10.

Slaoui said that means, if approved, the vaccine could be rolled out the next day.
"Our plan is to be able to ship vaccines to the immunization sites within 24 hours from the approval, so I expect maybe on day two after approval on the 11th or the 12th of December," he told CNN Sunday morning.
Remember: Experts have said that initially there won't be enough vaccine for everyone. The highest-priority groups, which include health care workers, the elderly and people with underlying medical conditions, will get the vaccine first.

1 hr 43 min ago

White House vaccine czar says he expects children could receive a vaccine by mid-2021

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Dr. Moncef Slaoui, the White House vaccine czar, told CNN's Jake Tapper today that he expects children will be able to receive the coronavirus vaccine some time in the middle of next year.

Slaoui, who is the head of the US government's efforts to develop a vaccine, said at this point the lowest age that children have received a vaccine during the trials has been 12- to 14-year-olds in the Pfizer trials.

"I don't know whether the FDA will approve the vaccine for use down to that age. Maybe they will stop at 18 years of age and above," he said.

Slaoui said that the government is planning to run clinical trials into younger adolescents, and then toddlers and infants on "an expedited basis" in the coming months.

He said that he expects by May 2021 that " toddlers, 4, 5 years old and down to 12 months old" could receive a vaccines, adding that first, "we need to run those clinical trials on an expedited basis."
 
1 hr 39 min ago

Where things stand in the race for a Covid-19 vaccine​

From CNN's Health team

Pfizer Covid-19 vaccine vials.


Pfizer Covid-19 vaccine vials. Pfizer

Drugmaker AstraZeneca announced on Monday that its experimental coronavirus vaccine has shown an average efficacy of 70% in large-scale trials — the latest of several vaccine trials worldwide to post their results this month.

The news follows Pfizer and BioNTech announcement Friday that they submitted to the US Food and Drug Administration for emergency use authorization for their coronavirus vaccine candidate. The agency could make a decision early next month about whether to issue an emergency use authorization, according to a source.

Here's a look at the major developments announced by Covid-19 vaccine makers:

Pfizer
  • Nov. 20: Pfizer submitted their application for emergency use authorization to the Food and Drug Administration.
  • Pfizer announced last week that its vaccine has a 95% efficacy rate. They included more data than they have before – looking at 170 confirmed cases of Covid-19, and they said it has 94% efficacy for people 65+.
  • Dec. 10: The FDA advisory committee will meet to discuss Pfizer’s EUA application.
  • If given a green light, the CDC's vaccine advisory committee will meet within 24-48 hours and make a recommendation on who should be first to get the vaccine. Shots in arms are expected to begin after that recommendation is made, likely on determination of priority.
  • Based on current projections, Pfizer expects to produce up to 50 million vaccine doses in 2020, and up to 1.3 billion doses in 2021. They have not said how much of that would be for the US.
  • Pfizer said last week it would test distribution of its coronavirus vaccine candidate in four states to see how hard it will be to deal with a product that has to be kept at temperatures well below the capacity of standard freezers.
Moderna
  • Nov. 17: Moderna announced efficacy results from a data safety monitoring board (DSMB). Initial results show 94.5% efficacy, with no significant side effects.
  • FDA and CDC will make their determinations and recommendations, similar to the process outlined above for Pfizer.
  • Moderna expects to have 20 million doses ready for the US by the end of the year.
  • Same timeline as outlined by Dr. Anthony Fauci for Pfizer.
AstraZeneca
  • Nov. 23: AstraZeneca announced their vaccine candidate has shown an average efficacy of 70%.
  • This week: The company will show data to the FDA and regulators in Europe.
Johnson & Johnson
  • Nov. 19: Johnson & Johnson announced they expect efficacy results by January or February of 2021.
  • The trial expects to reach its enrollment goal of 60,000 participants by the end of the year.
Novavax
  • Nov. 9: The vaccine maker announced last week it received fast-track designation from the FDA for its vaccine candidate.
  • Novavax expects to begin its Phase 3 trial in the US and Mexico by the end of November. The vaccine candidate will require two doses with hopes to deliver 100 million units by the end of the year.
Medicago-GSK
  • Nov. 12: Biopharmaceutical company Medicago and GlaxoSmithKline announced that Phase 2/3 clinical trials are set to begin for a Covid-19 vaccine candidate.
  • The trial evaluates the efficacy, safety and immunogenicity of Medicago's experimental vaccine combined with GlaxoSmithKline's booster.
  • The Phase 3 part of the study will start before the end of this year and will evaluate the efficacy and safety of the vaccine candidate compared to a placebo in more than 30,000 subjects across North America, Latin America and/or Europe and within the same population – or a broader one pending approval by regulatory authorities.
 
纽约时报的疫苗tracker进入第3期试验的疫苗共有13个,有限批准使用的疫苗共有6个。

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除加拿大报道的12个3期疫苗以外,加上澳大利亚默多克儿童研究所的在卡介苗基础上研发的疫苗。
PHASE 3
Murdoch Children’s Research Institute logo

The Bacillus Calmette-Guerin vaccine was developed in the early 1900s as a protection against tuberculosis. The Murdoch Children’s Research Institute in Australia is conducting a Phase 3 trial called the BRACE to see if the vaccine partly protects against the coronavirus.

6个有限批准使用的疫苗:

1. PHASE 3 APPROVED FOR LIMITED USE IN CHINA
The Chinese company CanSino Biologics

2. PHASE 3 APPROVED FOR EARLY USE IN RUSSIA
The Gamaleya Research Institute,


3. PHASE 1 PHASE 2 COMBINED PHASES APPROVED FOR EARLY USE IN RUSSIA
On Aug. 26, the Vector Institute


4. PHASE 3 APPROVED FOR LIMITED USE IN U.A.E.
The Wuhan Institute of Biological Products


5. PHASE 3 APPROVED FOR LIMITED USE IN U.A.E.
In addition to their Wuhan vaccine, Sinopharm


6. PHASE 3 APPROVED FOR LIMITED USE IN CHINA
Sinovac Biotech


 

国产新冠疫苗最新进展:国药集团已提交疫苗上市申请​


2020-11-25 12:03:17  21世纪经济报道 21财经APP 朱萍


据新华财经25日消息,中国国药集团有限公司副总经理石晟怡表示,中国国药集团已向国家药监局提交了新冠疫苗上市申请。
2月1日,国药集团中国生物作为牵头单位获得了科技部国家重点研发计划“公共安全风险防控与应急技术装备”重点专项灭活疫苗项目的紧急立项。4月12日,武汉生物制品研究所研发的新冠灭活疫苗获得了临床试验批件,并同步开展国内I/II期临床试验。4月27日北京生物制品研究所研发的新冠灭活疫苗再次获得临床试验批件,为新冠疫苗的研发加上双保险。

国内I/II期临床研究,各年龄段共计入组4064人,揭盲结果显示疫苗接种后,安全性好,不同年龄、不同程序、不同剂量疫苗接种后均产生高滴度免疫应答,两支疫苗按照0,28天程序接种两剂后,中和抗体阳转率均达100%。

此前据国药集团董事长、党委书记刘敬桢介绍,国药集团中国生物所属的北京生物制品研究所和武汉生物制品研究所这两款灭活疫苗现在正在阿联酋、巴林、埃及、摩洛哥、秘鲁、阿根廷等十个国家开展III期临床试验,目前已经接种5万余人,总共接种者将达到6万余人,接种人群样本量涵盖125个国籍,各方面进展领跑全球,得到国际广泛的认可。现在已经有几十个国家向国药集团中国生物提出新冠疫苗的需求。

在III期临床试验取得安全性和保护力数据以后,疫苗经审评获批就可以上市。实际上,目前我国已经有疫苗已经开始紧急使用。国药集团中国生物的的两支灭活疫苗,均纳入了紧急使用的范围。据介绍,目前中国生物已做好大规模生产准备工作,北京生物制品研究所、武汉生物制品研究所两个新冠疫苗高等级生物安全生产车间已经建设完成,明年产能预计将达到10亿剂以上,能够保证安全充足的疫苗供应。
 

Canada's 'glaring' vaccine production gaps took homemade vaccine candidates off the table​

Author of the article:
Elizabeth Payne
Publishing date:
Nov 27, 2020 • Last Updated 16 hours ago • 3 minute read

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Vaccine file photo PHOTO BY REUTERS

Canada’s inability to make large numbers of vaccines quickly took some promising made-in-Canada vaccine candidates off the table, says a member of the task force that recommended which COVID-19 vaccines Canada should buy.

“When we reviewed and made recommendations about which vaccines to buy, we first and foremost looked at the science. But we also looked at whether this vaccine could actually be made in time to deal with this pandemic,” said leading scientist and task force member Alan Bernstein.

“We were concerned that we would be approving vaccines that would never get made.”

In the end, the task force recommended the government purchase seven candidate COVID-19 vaccines, including some that have already reported successful results and at least one that could be approved by Health Canada in a matter of weeks. The sole Canadian vaccine on that list — from Quebec-based Medicago — has manufacturing facilities in the United States.



The pandemic has put Canada’s lack of capacity to make vaccines in a spotlight. The situation reflects changes in the industry in recent decades and complacency by successive federal governments going back years, said Bernstein, who is president and CEO of CIFAR, a Canadian-based global research organization. It is something that needs to be fixed before the next emergency, he said.
“We are not going to be able to build a new national facility capable of turning out 80 million doses in a short period of time. It is not going to happen for this pandemic. But it doesn’t mean we shouldn’t learn the lesson for the next one. And there will be a next one.”

MORE ON THIS TOPIC​

A woman holds a small bottle labeled with a

The Canadian connection to a promising COVID-19 vaccine​


This week, Health Minister Christine Elliott announced that Ontario expects to receive 2.4 million doses of COVID-19 vaccines from Pfizer and Moderna in the first quarter of 2021.

Ottawa prepares for an unprecedented vaccination campaign​


Although the federal government has made deals to purchase more vaccine per capita than any other country in the world, Prime Minister Justin Trudeau warned this week that Canadians would not be at the front of the line for those vaccines because the earliest doses are all being manufactured outside of Canada.
Canada has advance purchase agreements that would total up to 414 million vaccine doses. On Thursday, federal officials said they expect six million doses of at least two or three candidate vaccines to be delivered to Canada in the first quarter of 2021. Some of those vaccines require two doses, which means the first shipments will cover a small proportion of the Canadian population and will be given to those at the highest risk.

Deputy Chief Public Health Officer Howard Njoo said early vaccine supplies will be limited, but he is hoping that every Canadian has access to one by the end of 2021.

Bernstein said a hollowing out of the pharmaceutical industry, combined with government complacency about Canada’s ability to buy vaccines offshore, left the country with little manufacturing capacity. The SARS outbreak could have spurred change, but it ended too quickly for a vaccine, he said.

“We didn’t learn lessons from SARS that we need our own capacity in Canada to make our own vaccines in case of emergency.”

But the COVID-19 pandemic, he said, has made that clear.

Bernstein said the vaccine task force became so concerned about Canada’s lack of vaccine capacity that it created a subcommittee to look into the issue and make recommendations.

Bernstein said the UK is building a facility near Oxford, a collaboration among the government, academia and industry, that would be a good model for something similar in Canada. He said it could require an investment of up to $1 billion.

The federal government has invested millions to expand National Research Council facilities near Montreal for vaccine manufacturing. Earlier this year, it said the facility would be able to produce 250,000 vaccine doses per month as of now. But it isn’t ready.

That facility could be the start of a larger manufacturing and pandemic centre, said Bernstein. It would need to be able to manufacture vaccines using new and changing technology. He also said the facility could become a centre of pandemic preparedness, offering courses and training.

Nearly nine months into the pandemic, Bernstein said there is plenty to be optimistic about, starting with vaccine trial results from Pfizer and Moderna that are well above what he expected — with up to 95 per cent efficacy.

“To me, this is the hard part.”

Even if Canadians are not first in line to get immunized, he said, people will be vaccinated soon.

Bernstein said officials across the country need to turn their attention to the logistical challenges that distributing the various vaccines will present.

And then the country should look toward the future and “make sure we don’t get in this position again.”

 

英官方将评估牛津高有效率疫苗 “将错就错”数据如何出炉的?​

2020年11月27日早上7点51分
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图像来源,GETTY IMAGES
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英国政府已要求监管机构对牛津大学和阿斯利康公司共同研发的疫苗进行评估,这使英国离可能的全国性大规模接种计划更近一步。

英国政府表示,英国药品和健康产品监管局(MHRA)的评估标志着该款疫苗向 “获准接种”迈出“重要第一步”。英国卫生大臣马特·汉考克(Matt Hancock)表示,“我们已正式要求监管机构对牛津/阿斯利康疫苗评估,了解数据并确定其是否符合严格的安全标准。”

英国政府已预购1亿剂牛津疫苗。英国卫生和社会保障部(DHSC)表示,如果获得授权,英国将成为世界上首批接受该疫苗的国家之一,阿斯利康公司将在今年年底前为英国准备多达400万剂疫苗,2021年3月底前准备好4000万剂疫苗。

一周前,英国政府要求该机构对美国的辉瑞(Pfizer)疫苗进行评估。英国政府还订购4000万剂辉瑞疫苗。汉考克说,如果任何一款疫苗获得批准,英国的疫苗接种计划可以从12月开始推出。

本周牛津“阿斯利康疫苗”的三期临床数据让专家和公众疑惑。专家对其有效性提出质疑,呼吁等待披露完整数据和监管机构的评估。

三个有效率数据​

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图像来源,OXFORD UNIVERSITY

本周一(11月27日)牛津/阿斯利康疫苗的第三期临床数据显示疫苗总体有效率达70%。它给人们带来另一个希望,这种疫苗比辉瑞生物技术公司和莫德纳(Moderna)公司的mRNA疫苗更便宜、更容易分发。后者几天前宣布同样令人印象深刻的临床结果。

但欢欣鼓舞后,一些负面新闻随之而来。周四(11月26日)英国和美国的多家新闻机构报道有人对数据提出质疑。质疑集中在疫苗有效率,而非安全性。牛津疫苗公布的数据涵盖三个数据:总体有效率为70%,较低组的有效率为62%,较高组的有效率为90%。

这是因为试验中误用不同剂量的疫苗。有的志愿者被错误注射是原计划一半剂量的疫苗。然而,这个“错误 ”剂量却成了赢家。

这意味着什么?​

有些给志愿者接种的疫苗比原本设计的剂量弱,其中含有的成分要少得多,而这种成分是为了让人产生免疫力。该试验包括注射两针疫苗,两针间隔一个月,第二个针更像是第一针的增强剂。虽然大多数志愿者在试验中接种正确剂量的疫苗,但一些没有。

监管机构很早就被告知这个错误,他们同意试验可以继续进行,更多志愿者可以继续接种。该错误对疫苗安全性没有影响。

vaccine

结果如何?​

大约3000名参与者接种半剂量的疫苗,四周后接种第二针全剂量疫苗。这种方似乎提供最多的保护,即有效率达约90%。在更大的近9000名志愿者群体中,他们被给予两次全剂量的疫苗,时间间隔也是四周,这种方式产生的有效率为62%。

阿斯利康公司公布这些百分比,还说其疫苗的整体平均有效率为70%。这些数字让一些专家摸不着头脑。免疫专家、英国皇家国际事务研究所(Chatham House)全球健康项目副研究员大卫·索尔兹伯里(David Salisbury)教授说,“你把两个用了不同剂量的研究得出的数据综合, 但这个综合数据并不代表任何一组的情况。我想很多人对此都有异议。”

阿斯利康公司强调这些是初步数据,而非最终的完整数据。辉瑞和Moderna实验结果也是如此。这是媒体解读的科学。

所有公司都会在医学期刊上发表完整结果供公众监督。已经公布三期数据的三家厂商正在向监管机构提交完整数据申请紧急批准,这样各国就可以开始使用这3种不同疫苗来让整个人口产生免疫。

这会改变什么吗?

美国监管机构FDA称任何一款新冠疫苗需要提供至少50%的有效性才能获得审批。阿斯利康注射剂的最低有效性数据仍然通过该基准。有效性数据是基于对131例志愿者数据研究得出的结果。
  • 其中101例注射假新冠疫苗,(生理盐水注射剂或脑膜炎疫苗)
  • 其他30例折射真实疫苗--3人得注射半强度剂量,27人注射两针完整剂量
牛津大学的研究人员正在调查为什么一针弱剂量疫苗加完整剂量疫苗的组合比两针完整剂量疫苗的效果更好。一种解释是,先低后高的剂量可能会更好地模拟新冠病毒的感染路径,导致更好的免疫反应。

但有可能是接种半剂量的志愿者,和打了两针大剂量的志愿者年龄结构有些不同。为美国提供疫苗的计划的“曲速行动”(Operation Warp Speed)科学负责人蒙塞夫·斯劳伊(Moncef Slaoui)告诉美国记者,半剂量组只包括55岁以下的人。由于年龄是导致确诊新冠病毒重症患者的最大风险因素,因此一款能保护老年人的疫苗极为重要。

超过两万人参与牛津疫苗的试验(Credit: OXFORD UNIVERSITY/JOHN CAIRNS)

图像来源,OXFORD UNIVERSITY/JOHN CAIRNS
超过两万人参与牛津疫苗的试验

然而,早前发表在《柳叶刀》医学杂志上的牛津疫苗二期研究结果显示,该疫苗在所有年龄组都产生强烈的反应。

阿斯利康表示,“这些研究是按照最高标准进行。将继续积累更多数据,并将进行额外分析以完善疗效,确定保护时效。”伦敦帝国理工学院的专家彼得·奥普肖(Peter Openshaw)教授说:“我们必须等待完整数据,并等待监管机构的评估结果。”

 
2 hr 5 min ago

Why Oxford's Covid-19 vaccine could do more for the world than other shots​

From CNN's Emma Reynolds


A volunteer receives an injection at the Chris Hani Baragwanath hospital on the outskirts of Johannesburg, on June 24 as part of South Africa's first participation in an Oxford/AstraZeneca vaccine trial.
A volunteer receives an injection at the Chris Hani Baragwanath hospital on the outskirts of Johannesburg, on June 24 as part of South Africa's first participation in an Oxford/AstraZeneca vaccine trial. Siphiwe Sibeko/Pool/AP

In the days since Oxford University and AstraZeneca unveiled the results of the partnership's Phase 3 Covid-19 vaccine trials, a growing number of questions have emerged.
The stated 70% average efficacy was significantly lower than the 94.5% to 95% reported by the other two leading candidates, Moderna and Pfizer.

Yet this vaccine could still prove to be more valuable for the world than the other two in the coming months. If the questions over its results are answered and it receives approval, it may lead the way in providing vaccine coverage in poorer countries where it is urgently needed.

The UK government took the first step in that approval process on Friday, announcing that it had formally referred the candidate to the UK's medicines regulator for assessment.

"[T]he Pfizer vaccine is committed to its initial doses going to the EU and the US. And Moderna's supply will be tied up with the US for at least probably the first half of 2021, so in light of that, the Oxford/AstraZeneca vaccine is really good news for the rest of the world," Andrea Taylor, assistant director of programs at Duke Global Health Innovation Center, told CNN.
AstraZeneca has promised to supply hundreds of millions of doses to low and middle income countries and to deliver the vaccine on a not-for-profit basis to those nations in perpetuity. The vaccine developed at England's Oxford University is significantly cheaper than the others and, crucially, it would be far easier to transport and distribute in developing countries than its rivals since it does not need to be stored at freezing temperatures.

"I think it's the only vaccine that can be used in those settings at the current time," Azra Ghani, chair in infectious disease epidemiology at Imperial College London, told CNN.
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