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。

[Ottawa005]

专访：新冠疫苗接种 我们还在等什么？ – DW – 2020年9月5日

在打破记录的时间内研发出有效的新冠病毒疫苗，如何办到？这样没问题吗？是时候来深入思考一些问题了。

www.dw.com

德国之声：许多人似乎期待着疫苗可以解决所有问题，这样的期望是合理的吗？
卡姆拉德：如果现在可以研发出一种安全的疫苗，每两年需施打一次，但是可以改善整体情况的话，就令人满意了。这种疫苗可能无法防止流鼻涕或其他轻度症状。但是至少疫苗要能防止呼吸功能不全和严重的器官损伤。如果问我们在等待的是什么，我会回答，就是这个。如果疫苗能将病情由威胁性命的程度降低到轻症，我认为就是成功的。

德国之声：最近又有了新的感染消息，香港一名年轻人第二次被验出阳性。在此之前，社会上原本还存有感染者能免疫的希望。这条消息是否也意味着“群体免疫”的思路被推翻了呢？
卡姆拉德：无论如何，群体免疫过时了！看看所需的感染率以及相应的死亡率，这就是石器时代的方法，必须花上很久的时间。
因此我们必须假设人类无法永远免疫。希望不会再有人相信自然的群体免疫。想要群体免疫只能透过疫苗来达成。

 

[lindamy]

1 hr 21 min ago

Pfizer and BioNTech approved to start phase 2/3 trial of Covid-19 vaccine
From CNN’s John Bonifield and Frederik Pleitgen

The German regulatory authority, the Paul-Ehrlich-Institut, has approved a phase 2/3 clinical trial in Germany of a Covid-19 vaccine candidate being developed by US pharmaceutical company Pfizer and German biotechnology company BioNTech.

“The integration of sites in Europe, and now especially in Germany, is aimed at supporting an approval in Europe," said Ugur Sahin, CEO and cofounder of BioNTech, in a news release on Monday.

The BNT162b2 mRNA-based vaccine candidate is already in similar large-scale trials in the United States. The trial involves giving the participants two doses of a 30 microgram vaccine – one on the first day and one 28 days later – with participants being followed up for up to two years after they receive the second dose.

In August, the companies presented "promising" results in early data on safety and immune responses in their ongoing Phase 1/2 study in the United States. Among both younger and older adults in the trial, the companies said the vaccine "was well tolerated with mild to moderate fever in fewer than 20% of the participants." The companies also noted in their news release that seven days after participants were given a second dose of the vaccine at 30 micrograms, the vaccine was able to elicit neutralizing antibodies in younger adults ages 18 to 55, and in older adults ages 65 to 85.

Remember: The data has not yet published in a peer-reviewed medical journal.

The companies plan to seek regulatory authorization or approval for the drug as early as October if it is successful in clinical trial testing. They plan to supply up to 100 million doses worldwide by the end of 2020 and 1.3 billion doses by the end of 2021.

Many infectious disease experts say, however, that it’s highly unlikely Pfizer will have enough data to allow for an emergency use authorization from the US Food and Drug Administration in October.

 

[lindamy]

THE SCIENCE​

​

​

Sinovac says it coronavirus vaccine candidate appears to be safe in elderly people​

​

Chinese firm Sinovac Biotech Ltd. said on Monday its coronavirus vaccine appeared to be safe for older people, according to preliminary results from an early to mid-stage trial, Reuters reports, while the immune responses triggered by the vaccine were slightly weaker than for younger adults. Health officials have been concerned about whether experimental vaccines could safely protect the elderly, whose immune systems usually react less robustly to vaccines, against the virus that has led to hundreds of thousands of deaths worldwide. Sinovac's candidate CoronaVac did not cause severe side-effects in combined Phase 1 and Phase 2 trials launched in May involving 421 participants aged at least 60, Liu Peicheng, Sinovac's media representative, said. The World Health Organization is working with China on requirements for international approval of any Chinese COVID-19 vaccine, a senior official said on Monday. "WHO's office in China and WHO headquarters has been working with the regulatory authorities in China," assistant director-general Mariangela Simao told a briefing in Geneva. "We are in direct contact. We have been sharing information and the requirements for international approval of vaccines." Four of the world's eight vaccines that are in the third phase of trials are from China.​

 

[lindamy]

1 hr 39 min ago
Inovio plans to start Phase 2/3 clinical trials of Covid-19 vaccine this month
From CNN Health's John Bonifield & Elizabeth Cohen

The pharmaceutical company Inovio plans to begin a Phase 2/3 clinical trial of its Covid-19 vaccine candidate this month, according to company president and CEO Dr. Joseph Kim.

“We’re a few months behind some of the early leaders in the Phase 3 trials, but we feel the positive attributes of our DNA vaccine will provide a great alternative in terms of safety and product stability and efficacy,” Kim told CNN Senior Medical Correspondent Elizabeth Cohen.

How it works: Inovio's vaccine technology works by delivering particles of DNA directly into cells, triggering an immune response to the novel coronavirus inside the cells.

The Phase 2/3 clinical trial was first announced in August on an earnings call.

Inovio plans to enroll 6,000 to 10,000 volunteers in the study. That’s less than the 30,000 volunteers who are being enrolled in clinical trials for several other Covid-19 vaccine candidates.

Kim said the trial will be smaller than others because they’ll be targeting high-risk people, such as factory workers.

In August, Inovio shared results of small a Phase 1 clinical trial involving 40 volunteers. Side effects were mild, and the vaccine showed evidence of neutralizing antibodies and T cell responses.

The data has not yet been published in a peer-reviewed medical journal.

Inovio’s Covid-19 vaccine is being funded, in part, by the US Department of Defense, the Bill & Melinda Gates Foundation, and The Coalition for Epidemic Preparedness Innovations.

The company has not received funding from Operation Warp Speed, the Trump administration’s initiative to fast-track the development and delivery of a Covid-19 vaccine.

Three Phase 3 trials have already started in the US. Two other companies are also scheduled to begin Phase 3 trials this month, according to Moncef Slaoui, chief adviser of Operation Warp Speed.

Sanofi and GlaxoSmithKline expect to start a Phase 3 trial in the US by the end of the year.

 

[lindamy]

33 min ago
AstraZeneca pauses coronavirus vaccine trial after unexplained illness in volunteer
From CNN's Maggie Fox

A man receives an injection as UCLA and AstraZeneca begin phase three trials in a potential COVID-19 vaccine. The Lundquist Institute/FILE

Drug giant AstraZeneca said Tuesday it had paused a trial of its coronavirus vaccine because of an unexplained illness in one of the volunteers.

It’s a standard precaution in vaccine trials, meant to ensure experimental vaccines don’t cause serious reactions among volunteers.

“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process triggered a pause to vaccination to allow review of safety data,” the company said in a statement sent to CNN.

“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” the statement added.

“In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully. We are working to expedite the review of the single event to minimize any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.”

Earlier Tuesday, AstraZeneca joined eight other companies in signing a pledge promising they would not seek premature government approval for any coronavirus vaccine. They promised they would wait until they had adequate data showing any potential vaccine worked safely to prevent infection.

The AstraZeneca vaccine is one of three coronavirus vaccines in late-stage, Phase 3 trials in the US.

It was not immediately clear if the pause involved only US trial sites or all of the company’s trial sites around the world. A Data and Safety Monitoring Board usually monitors trials for adverse events and can order a pause or halt to a trial, but AstraZeneca did not say who had stopped the trial.

An AstraZeneca spokesperson later said the illness affected a participant in Britain, but said all of the company’s trials of the vaccine globally would be paused.

 

[lindamy]

2 hr 53 min ago

Phase 3 clinical trials of Sputnik V coronavirus vaccine to begin today: Health minister

From CNN’s Zahra Ullah and Anna Chernova in Moscow

An employee works at the Moscow-based Gamaleya Institute, where a vaccine named Sputnik V -- a reference to the 1957 Soviet Union satellite -- is being produced using funding from the Russian Direct Investment Fund (RDIF). Vyacheslav Prokofyev/TASS/Getty Images

The third phase of clinical trials of the Sputnik V vaccine will begin today, Russia's Health Minister Mikhail Murashko said Wednesday, according to the country's state news agency TASS.

"Today, the third phase of clinical trials on the [coronavirus] vaccine, created the first in the world in the Russian Federation, are starting," Murashko said at a medical conference on Wednesday.

Russia drew criticism in August when it announced the world's first approved Covid-19 vaccine for public use -- before crucial Phase 3 trials were completed.

Since Russia registered the vaccine on August 11, these trials are also referred to as post-registration clinical trials of Sputnik-V.

 

[向问天]

 

[lindamy]

3 hr 13 min ago
Oxford University's coronavirus vaccine trials will resume
From CNN’s Niamh Kennedy and Katie Polglase

The Oxford University coronavirus vaccine trials will resume after being halted Sunday after an unexplained illness in one of its volunteers, the university said in a statement today.

The university, which is working with drug giant AstraZeneca, did not say what day the trial would resume.

"Globally some 18,000 individuals have received study vaccines as part of the trial. In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety," the statement said.

 

[向问天]

3 hr 13 min ago
Oxford University's coronavirus vaccine trials will resume
From CNN’s Niamh Kennedy and Katie Polglase

The Oxford University coronavirus vaccine trials will resume after being halted Sunday after an unexplained illness in one of its volunteers, the university said in a statement today.

The university, which is working with drug giant AstraZeneca, did not say what day the trial would resume.

"Globally some 18,000 individuals have received study vaccines as part of the trial. In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety," the statement said.

一个是脊髓炎，另外一个高烧不退。
恢复了更糟。

 

[lindamy]

国产新冠灭活疫苗已紧急接种数十万人 无一例不良反应 零感染

环球网
09月11日 13:27关注

　零感染！国产新冠灭活疫苗已紧急接种数十万人

国药中国生物研制的两款新冠灭活疫苗已经接种了数十万人次，无一例明显不良反应，无一人感染。

国药集团中国生物负责人日前就新冠灭活疫苗紧急使用和海外Ⅲ期临床研究情况接受媒体采访时透露，国药中国生物研制的两款新冠灭活疫苗已经接种了数十万人次，无一例明显不良反应，无一人感染；其中打完疫苗之后去往海外高风险国家和地区的数万人，截至目前零感染。


（资料图）

国药中国生物总法律顾问周颂介绍，国内新冠灭活疫苗获批临床试验的有三支，国药中国生物就占了其中两支，也是目前紧急使用接种量最大、人数最多的。周颂强调，意义更为重大的是，新冠灭活疫苗的紧急使用，面向的都是高风险暴露人群，比如救治新冠病毒感染者的医护人员，以及去往疫情高风险国家的外交人员、外派员工和中资企业“一带一路”建设人员等等。这几万人打完疫苗之后，已经到海外几个月时间了，其中在疫情暴发的地区，有留守的员工感染了，他们没有感染。类似这样的平行对照数据在多个国家都有，这证明了疫苗的有效性。

国药中国生物副总裁张云涛表示，新冠灭活疫苗Ⅰ、Ⅱ期临床研究在国内开展，都产生了中和抗体。“中和抗体检测是个金标准”，在海外的Ⅲ期临床研究中，也会持续观察中和抗体。中和抗体是可比较的，在海外的试验扩大了人种、国家和人群，最主要还是被海外认可，对于以后的应用会更好。

张云涛说，以前我们的疫苗想出口是很难的，有一系列的法规和临床限制。现在我们的科技实力强了，Ⅰ、Ⅱ期临床试验数据被海外认可，在海外直接开展Ⅲ期临床研究，是国际合作的典范。未来，中国审批通过，这些国家只要做了临床研究，也都可以合法合规上市。他透露，目前，新冠灭活疫苗在国际上有5亿剂意向订单。


科技日报报道截图

来源：科技日报/瞿剑

责任编辑：刘万里 SF014

国产新冠灭活疫苗已紧急接种数十万人 无一例不良反应 零感染

国产新冠灭活疫苗已紧急接种数十万人 无一例不良反应 零感染

finance.sina.cn

 

[lindamy]

3 hr 4 min ago
UAE approves "emergency use" of coronavirus vaccine for frontline workers
From CNN’s Nada AlTaher and Sarah El Sirgany in Abu Dhabi

A staff member takes out samples of the Covid-19 inactivated vaccine at a vaccine production plant of China National Pharmaceutical Group Sinopharm, in Beijing, on April 11. Zhang Yuwei/Xinhua/Getty Images

The United Arab Emirates has approved the “emergency use” of a coronavirus vaccine for frontline workers, according to the country’s health minister.

“Studies show that the vaccine is efficient and safe and showed a positive response in generating antibodies,” Abdul Rahman al-Owais, Minister of Health and Prevention, said at a televised press briefing Monday.

“The vaccine will be optional for frontline workers most exposed to the virus,” al-Owais said.

The announcement of the emergency use vaccine came as the minister was discussing ongoing phase 3 trials in the UAE of a vaccine developed by China’s state-owned Sinopharm pharmaceutical company.

China has been using an experimental vaccine developed by Sinopharm’s China National Biotec Group Company (CNBG) on people who work in high-risk professions since July, including frontline medical professionals, a senior official from the national health commission revealed in August.

 

[Ottawa005]

中国-普通人最早11月可接种，已經要正式上市了

中国称全球9种三阶临床试验新冠疫苗中5种来自中国 普通人最早11月可接种

9月14日晚间，中国疾病预防控制中心生物安全首席专家武桂珍在中国央视一档新闻节目当中，对新冠疫情和疫苗的进展做了解释，并透露中国民众最早可以从11月开始接种新冠疫苗。

www.rfi.fr

 

[lindamy]

作为6000名志愿者之一，巴林王储接受中国国药集团3期灭活疫苗试验注射。

44 min ago
Crown Prince of Bahrain receives injection as part of phase 3 Covid-19 vaccine trials
From CNN's Mohammed Tawfeeq

Bahrain's Crown Prince Salman bin Hamad bin Isa al-Khalifa stands at attention upon his arrival for a meeting with Italy's prime minister on February 3, in Rome. Alberto Pizzoli/AFP via Getty Images

Bahrain's Crown Prince Salman bin Hamad al-Khalifa has received a coronavirus vaccine injection as part of the phase 3 trials underway in the country, according to state media.

"The phase III clinical trials are being conducted in collaboration with Abu-Dhabi based G42 Healthcare using a vaccine developed by Sinopharm CNBG, the sixth-largest producer of vaccines in the world," Bahrain’s state-run news agency said on Wednesday.

Sinopharm, a Chinese state-owned pharmaceutical company, launched a phase 3 trial of its coronavirus vaccine in the United Arab Emirates in June in partnership with G42.

Al-Khalifa is among 6,000 volunteers participating in the trials "selected from those who meet the required medical criteria," according to the report.

"I was privileged to stand together with our vaccine volunteers, each one of them determined to play their part in working to protect others, not just at home in our Kingdom, but right across the globe," al-Khalifa was quoted as saying.

 

[向问天]

作为6000名志愿者之一，巴林王储接受中国国药集团3期灭活疫苗试验注射。

44 min ago
Crown Prince of Bahrain receives injection as part of phase 3 Covid-19 vaccine trials
From CNN's Mohammed Tawfeeq

Bahrain's Crown Prince Salman bin Hamad bin Isa al-Khalifa stands at attention upon his arrival for a meeting with Italy's prime minister on February 3, in Rome. Alberto Pizzoli/AFP via Getty Images

Bahrain's Crown Prince Salman bin Hamad al-Khalifa has received a coronavirus vaccine injection as part of the phase 3 trials underway in the country, according to state media.

Sinopharm, a Chinese state-owned pharmaceutical company, launched a phase 3 trial of its coronavirus vaccine in the United Arab Emirates in June in partnership with G42.

Al-Khalifa is among 6,000 volunteers participating in the trials "selected from those who meet the required medical criteria," according to the report.

"I was privileged to stand together with our vaccine volunteers, each one of them determined to play their part in working to protect others, not just at home in our Kingdom, but right across the globe," al-Khalifa was quoted as saying.

巴林王储啊。
阿拉伯人是相信中国的

 

[lindamy]

全球领先冲刺处于三期的10支疫苗，其中俄国一支已获批准，但是跳过了二期试验。美国Novavax Protein subunit疫苗新近进入3期试验。

https://newsinteractives.cbc.ca/coronavirusvaccinetracker/#non-replicating-viral-vector