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。

[lindamy]

2 hr 31 min ago
Inside the multibillion dollar vaccine race
From CNN's Eliza Mackintosh, Gianluca Mezzofiore and Katie Polglase

CNN

Four years. That’s the fastest a vaccine has ever been developed -- and most take 10 to 15.

But scientists are now racing to do it in under one.

Dozens of research teams around the world are working to develop a vaccine for SARS-CoV-2, the virus that causes Covid-19, using a mix of established techniques and new technologies.

Funding for a vaccine has never been greater, with billions of dollars pouring in from around the world to make a product that could help to control the pandemic -- but the US, China and Europe have invested the most.

Before even the most vulnerable groups can get a shot in the arm from their family doctor, however, a lot of work needs to be done -- and a lot of deals need to be made.

As the coronavirus continues to accelerate unabated, here’s what it will take to bring a vaccine to the masses and how each of the three biggest players are faring in their quest to make it happen as quickly as possible.

Read

CNN's interactive on the path to a Covid-19 vaccine.

 

[lindamy]

6 hr 25 min ago
UK government secures early access to 90 million doses of two "promising" vaccine candidates
From CNN's Milena Veselinovic

The British government has secured early access to 90 million doses of two "promising" vaccine candidates, the Department for Business, Energy & Industrial Strategy said in a statement today.

According to the "in-principle" agreement, Britain has secured 60 million doses of the Novavax vaccine and 30 million doses of the Janssen vaccine.

Ministers have also agreed "in principle" to co-fund a global clinical study of the Janssen vaccine. It will examine whether two doses of their vaccine candidate given to participants provides long-term protection against coronavirus.

Novavax will conduct a Phase 3 clinical trial of the vaccine working with the UK's National Institute for Health Research (NIHR), and has plans to manufacture some of the vaccine in Britain.

"This will ensure that, once available, the vaccine can be supplied to the British public as soon as possible," the UK government statement said.
"If the vaccines are safe and successful in clinical trials, both could be delivered to the UK in mid-2021. They would be given first to priority groups such as frontline health and social care workers, ethnic minorities, adults with serious diseases, and the elderly."

The UK has so far secured access to six different vaccine candidates across four different vaccine types, the government says.

“The government’s strategy to build a portfolio of promising vaccine candidates will ensure we have the best chance possible of finding one that works," Business Secretary Alok Sharma said on Friday.

 

[lindamy]

1 hr 18 min ago
Early results suggest Chinese vaccine is safe and induces immune response, but more research is needed
From CNN's John Bonifield and Dana Vigue

Interim results of phase one and two trials published in the Journal of the American Medical Association suggest a coronavirus vaccine developed by the Chinese pharmaceutical company Sinopharm is safe and induces an immune response.

However, researchers said more study is needed to know whether the vaccine protects people against the virus.

The phase one trial, conducted in Henan Province, China, involved 96 people given high, medium or low doses of the vaccine, or a placebo, which does nothing. The Phase 2 trial, involved 224 adults given the medium dose of the vaccine, or a placebo.

Within seven days after injection, adverse reactions were reported in 15% of trial participants. The most common adverse reaction was injection site pain, followed by fever. All adverse reactions were mild and did not require any treatment.

In the phase two study, the vaccine prompted a neutralizing antibody response in 97.6% of participants. The researchers found that participants had greater neutralizing antibody responses when they were given the second dose of the vaccine three weeks after the first dose rather than two weeks after the first dose.

"My impressions is that they are getting reasonable levels of virus neutralizing antibodies," Dr. Peter Hotez, a vaccinologist at Baylor College of Medicine and a CNN medical analyst, said. "Based on this and safety profile, I believe that this is definitely a vaccine worth pursuing in Phase three clinical trials. I also think that this could be as good as the Operation Warp Speed vaccines in terms of efficacy and safety, but we really need those large trials."

Some background: The US government is supporting six vaccine candidates so far through the Trump administration's Operation Warp Speed program. Two have moved into large, phase three trials on tens of thousands in the United States.

There are 29 vaccines in clinical trials worldwide, according to the World Health Organization.

 

[lindamy]

俄羅斯搶先批准的是一個什麼樣的新冠疫苗？

来源: 乔探长 于 2020-08-18 21:10:45

8月11日，俄羅斯宣佈他們的新冠疫苗已經研發成功並獲得批准。他們將於近日投入生產並讓健康人羣使用。這個消息一經宣佈，震驚了世界。因為在這個消息宣佈的8月以前，根本就沒有俄國疫苗的研發信息。

為什麼俄羅斯新冠疫苗可以在毫無信息的情況下突然被宣布成為世界第一個成功的疫苗呢？原來俄羅斯政府繞過了第三期人體臨床試驗而直接批准了這個疫苗的使用。而且有關這個疫苗動物試驗、第一和第二期人體臨床試驗的結果也沒有被公布出來。也正是這個原因，大家對這個疫苗了解並不太多。

那麼，這個俄羅斯疫苗究竟是個什麼樣的疫苗呢？有關這個疫苗究竟是何方神聖的報道並不多，所幸從許多七零八碎的描述中還是可以了解這個疫苗的一個大概，下面是有關這個疫苗的一些信息。

這個疫苗是由俄國政府的一個叫做“莫斯科加瑪利亞（Gamaleya）流行病和微生物研究所研發。它一共花了俄羅斯政府40億盧布，也就是5千5百萬美元。這個疫苗號稱已經通過了動物試驗以及第1和第2期的人體臨牀試驗，據稱試驗結果良好。雖然這個疫苗已經被批准，但是第3期的人體臨床試驗將不會被忽略，將會在近期啟動。

這個疫苗一共需要打兩針。第一針是用一個叫做Ad26的腺病毒載體接入一個新冠病毒的S-蛋白基因所做出來的疫苗，這個疫苗與美國強生公司（Johnson&Johnson）正在研發的疫苗非常類似。相隔一個月左右，再打第二針加強一下。這個第二針是用一個叫做Ad5的腺病毒載體接入一個新冠病毒的S-蛋白基因所做出來的疫苗，這個疫苗與中國陳薇團隊正在研發的疫苗也非常相似。俄羅斯把中美兩國的精髓綜合起來，第一針用的是美國的，第二針用的是中國的，兩針下去以後，變成了俄羅斯的。

俄羅斯總統VladimirPutin通過全國性電視告訴大家這個疫苗相當有效，能產生穩定的免疫力。Putin進一步告訴大家他的一個女兒已經接受了疫苗注射，除了只有一天有點輕微的發燒現象，其它沒有任何問題。俄國研發單位的主要負責人Alexander 和科學家們也都注射了疫苗，研發單位的另一位負責人Kirill也說他和他的家人都注射了疫苗。

由於對這個疫苗的測試結果沒有公布，更是因為這個疫苗還沒有經過第三期的人體臨床試驗的驗證，所以俄羅斯政府對這個疫苗的批准引來了學界和媒體的批評，許多學者專家對這個疫苗的安全性和有效性提出了質疑。

雖然有批評聲和質疑聲，俄羅斯的第一批疫苗還是於8月15日被生產了出來。俄羅斯政府表示，有大約20個國家已經預先下了超過10億劑俄羅斯疫苗的訂單。另外，印度、印度尼西亞和一些非洲國家也對他們的疫苗表示了購買的意願。越南已經公開表示願意購買5千萬到1億5千萬劑的俄羅斯疫苗。

https://bbs.wenxuecity.com/health/924030.html

本文內容來源：https://www.youtube.com/watch?v=UFZOXiodaD

 

[lindamy]

https://www.bilibili.com/video/BV1XD4y1U77f/

中国疫苗在迪拜阿布扎比进行第三期试验，1500名各国籍志愿者参加。

 

[向问天]

https://www.bilibili.com/video/BV1XD4y1U77f/

中国疫苗在迪拜阿布扎比进行第三期试验，1500名各国籍志愿者参加。

是15000

 

[向问天]

有人对疫苗有莫名其妙的恐惧，他们自以为他们自己最聪明，但是至今全世界几百个疫苗在实验，没有发生一例死亡。

@阿土仔

 

[阿土仔]

有人对疫苗有莫名其妙的恐惧，他们自以为他们自己最聪明，但是至今全世界几百个疫苗在实验，没有发生一例死亡。

@阿土仔

往常这类疫苗需要多长时间？这次多长时间？往常疫苗研制是有意磨洋工吗？没死人的就是好疫苗？

你愿意打中国的疫苗我不拦着，你自己觉得怎么聪明就怎么办。

 

[lindamy]

Indonesia signs agreement with Sinovac for Covid-19 vaccine

Sinovac granted priority access for bulk supply to Indonesia until the end of 2021.PHOTO: REUTERS
PUBLISHED
AUG 22, 2020, 2:49 PM SGT
FACEBOOKTWITTER

JAKARTA (BLOOMBERG) - Indonesia has signed an agreement with China's Sinovac Biotech for 50 million doses of Covid-19 vaccine concentrate that will allow state-owned PT Bio Farma to produce doses locally.

Sinovac will ship the concentrate in five equal stages between November and March, vaccine maker Bio Farma said in a statement on Saturday (Aug 22).
Beijing-based Sinovac also granted priority access for bulk supply to Indonesia until the end of 2021.

The government is also seeking a possible partnership with Chinese pharmaceutical company Sinopharm Group, Foreign Minister Retno Marsudi said on her Twitter account on Friday.

About 150,000 Indonesians have tested positive for Covid-19, with fatalities reaching 6,500 as of Aug 22, Johns Hopkins University data shows.

Bio Farma will increase its manufacturing capacity to 250 million doses by the end of the year from about 100 million now, the company said.

The Covid-19 vaccine concentrate will require a series of tests and should be registered with the Indonesian Food and Drug Monitoring Agency before mass production.

Indonesia signs agreement with Sinovac for Covid-19 vaccine

JAKARTA (BLOOMBERG) - Indonesia signed an agreement with China's Sinovac Biotech for 50 million doses of Covid-19 vaccine concentrate that will allow state-owned PT Bio Farma to produce doses locally. Read more at straitstimes.com.

www.straitstimes.com

 

[向问天]

往常这类疫苗需要多长时间？这次多长时间？往常疫苗研制是有意磨洋工吗？没死人的就是好疫苗？

你愿意打中国的疫苗我不拦着，你自己觉得怎么聪明就怎么办。

注射了疫苗就减少或者避免了感染真病毒的机会。我肯定愿意。真病毒弄死人是铁板钉钉的事实吧。

可惜，加拿大没有疫苗。

 

[lindamy]

China giving experimental coronavirus vaccines to high-risk groups since July, says official

ROXANNE LIU AND YEW LUN TIAN
REUTERS
PUBLISHED 7 HOURS AGOUPDATED AUGUST 22, 2020




A nurse holds China's Sinovac vaccine, a potential vaccine for the coronavirus disease (COVID-19), August 8, 2020.
DIEGO VARA/REUTERS

China has been giving experimental coronavirus vaccines to groups facing high infection risks since July, a health official told state media.

No vaccine has yet passed final, large-scale trials to prove it is safe and effective enough to protect people from contracting the virus that has led to almost 800,000 deaths worldwide.

The aim is to boost the immunity of specific groups of people, including medical workers and those who work at food markets and in the transportation and service sectors, Zheng Zhongwei, a National Health Commission official, told state TV in an interview aired late on Saturday.

Authorities could consider modestly expanding the emergency use programme to try to prevent possible outbreaks during the autumn and winter, added Zheng, who heads the Chinese government-led team that coordinates state resources for coronavirus vaccine development.

The guidelines for emergency use of potential coronavirus vaccines, approved on June 24 according to Zheng, have not been made public.

State media Global Times reported in June that China had been offering candidate coronavirus vaccines to employees at state-owned firms travelling overseas.
Some countries are sceptical about China’s use of experimental vaccines. Papua New Guinea has denied entry to Chinese nationals who participated in a coronavirus vaccine trial, according to the Australian newspaper.

China’s coronavirus vaccines will be priced close to cost, Zheng said.

“It does not mean that companies cannot make profits,” Zheng said. “Companies should decide on moderate profits, or reasonable profits based on costs.”

A potential coronavirus vaccine being developed by a unit of China National Pharmaceutical Group (Sinopharm) could cost no more than 1,000 yuan ($144) for two shots, Sinopharm chairman Liu Jingzhen told state media last week.

“[The price] will definitely be lower than what Liu said,” Zheng said.

China giving experimental coronavirus vaccines to high-risk groups since July, says official

No vaccine has passed large-scale trials to prove it is safe and effective yet, but China has been giving experimental vaccines to people facing high infection risks

www.theglobeandmail.com

 

[lindamy]

中国将向巴基斯坦提供新冠疫苗
据巴基斯坦政府官员称，中国将向巴基斯坦提供冠状病毒疫苗，作为在这个南亚国家进行疫苗试验的协议的一部分。
Saeed Shah
2020年8月15日09:10 CST 更新

府官员称，中国将向巴基斯坦提供冠状病毒疫苗，作为在这个南亚国家进行疫苗试验的协议的一部分。

巴基斯坦是中国在发展中国家中最亲密的盟友之一，该国将在早期获得足够的疫苗，为其2.2亿人口中最脆弱的人群接种疫苗，其中包括老年人、医护人员和那些患有可能导致新冠重症的基础疾病的人。

官员们说，疫苗将大约覆盖五分之一的人口。

官员们表示，正在与第二家中国公司进行谈判，以便在巴基斯坦进行疫苗试验。
...

中国将向巴基斯坦提供新冠疫苗

据巴基斯坦政府官员称，中国将向巴基斯坦提供冠状病毒疫苗，作为在这个南亚国家进行疫苗试验的协议的一部分。

cn.wsj.com

 

[阿土仔]

注射了疫苗就减少或者避免了感染真病毒的机会。我肯定愿意。真病毒弄死人是铁板钉钉的事实吧。

可惜，加拿大没有疫苗。

我只打有质量保证的疫苗，这年头把聋子治成哑巴的不少。你们打吧，我看着......

 

[lindamy]

新冠疫情：疫苗研发竞赛中的抄近路、耍阴招和民族主义

• 2020年 8月 25日

图片版权RUSSIAN DIRECT INVESTMENT FUND

新冠疫情仍在全球大流行，而且有可能在2020年秋冬反扑。与此同时，国际新冠疫苗竞赛已进入加时赛，各国希望在此之前推出行之有效的疫苗有效控制疫情。

在这场竞赛中，“疫苗民族主义”加剧，有的国家被指走捷径、从事间谍活动、失去道德约束的冒险和嫉妒它国。俄罗斯已于八月中宣布投入使用一款人体测试不到两个月的疫苗“卫星五号”（Sputnik-V）。总统普京表示该疫苗已通过所需检测。

俄罗斯发布震惊国际的公告后的十多天，来自中国官媒一则消息也同样引发外界关注。

在8月22日晚中国央视《对话》栏目中，中国国务院联防联控机制科研攻关组疫苗研发专班工作组组长郑忠伟表示，中国已于7月22日正式启动新冠疫苗的紧急使用。他透露，中国官方在6月24日批准疫苗紧急使用方案。

但由中国国药集体研发的一款疫苗六月底才开始获准开启国际三期临床试验。

疫苗要经过临床三期试验后，验证其安全性才可继续往前推进。开发疫苗通常需要数年时间，本次新冠大流行的紧迫性和严重性，将疫苗研发的进程大大缩短。

目前尚不清楚中国已经紧急接种疫苗的具体人数。郑忠伟则表示，该疫苗是在一定范围、一定时限内紧急使用。目的是在医务人员、防疫人员、边检人员以及保障城市基本运行人员等特殊人群中，先建立起免疫屏障，整个城市的运行就会有稳定的保障。

图片版权EPAImage caption普京宣布俄罗斯自行研制的疫苗已经投入使用。

大打折扣的疫苗研发时间

新冠疫苗是现代社会最有价值，最受追捧的医学研究领域之一。这不仅因为它可以挽救生命，消除疫情的冲击，还可以为疫苗研发成功者带来荣耀和认可。

美国乔治敦大学全球卫生法教授劳伦斯·戈斯汀（Lawrence Gostin）说：“我从未见过（其它）医疗产品在政治上有如此大的利害关系。新冠疫苗的政治象征意义背后，是因为超级大国已将其视为展现自己国家科学实力的象征，证明政治制度优越性的手段。”

戈斯丁教授说：“我们为人类参与者研究制定了一套道德规范，旨在防止滥用行为。”

根据世界卫生组织（WHO）的数据，目前约有六款领先的新冠疫苗在进行三期试验，其中中国有三款；英国有一款；一款在美国，以及一款德美联合研制。
尽管所有研发者都在努力加快步伐，但俄罗斯研发的疫苗“卫星五号”（Sputnik-V）引发人们对缩短正常程序的担忧。

七月，英国，美国和加拿大指责俄罗斯的间谍机构入侵疫苗研究，克里姆林宫对此予以否认。当时情报显示，这项活动更多的是窃取数据而不是破坏疫苗研发。

图片版权EPA

接下来的一周，美国司法部指责两名中国黑客代表北京的情报部门针对疫苗研发下手。中国对此强烈否认，并表示已与世界共享病毒信息，并与外国合作。

科学家认为，更大的担忧其实是缩短通常缓慢而复杂冗长的疫苗医学试验。

美国乔治城大学外交关系委员会全球卫生计划主任托马斯·波利基（Thomas Bollyky）说：“就俄罗斯的例子来讲，肯定是走了捷径。研发疫苗并不难，难的是证明疫苗是否安全有效。而且如果各国只对疫苗本身感兴趣，他们可以走捷径。”

俄罗斯的做法招致西方科学家的质疑。白宫新冠病毒特别工作组中最杰出的一大成员福奇（Dr Anthony Fauci）博士说，他“严重怀疑”俄罗斯声称自身疫苗安全有效的说辞。在莫斯科，这种担忧被解读“嫉妒”。接种疫苗的人说，他们很快将在主要的国际科学杂志上发表数据。

同时， 中国也加快研发步伐。但中国7月底已开始紧急启用疫苗的消息，无疑让外界对疫苗的安全性更加担忧。

中国一些药企称，一些高管已经接种疫苗以提前测试疫苗。此举旨在表明负责人愿意承担风险并做出牺牲。在俄罗斯，总统普京的女儿也已接种疫苗。

有报道称，中俄两国在特定人群包括军队测试该疫苗引起道德上的担忧，因为这些人的同意可能有被强加的成份。中国医药公司康希诺与中国人民解放军合作研发的一种疫苗于6月获准在军队内部使用后才开始进行后期的“第三阶段”试验。

未能通过全面测试就将疫苗面世，可能会导致公众过度自信和新冠病毒的进一步传播。另外，一款具有严重副作用的疫苗可能会助长反疫苗接种运动。

图片版权GETTY IMAGESImage caption特朗普视察一家研发新冠疫苗的实验室。

疫苗背后的国家意志

大多数疫苗研发计划都是商业活动，通常由国际合作完成。但这并未阻止各国政府将其视为国家威望和科学实力的象征，这也是他们应对外界批评处理危机不力的手段。

波利基说：“某些国家在疫苗研发方面显得特别冒进，主要是源于他们国内担忧外界对其抗疫表现的评价。”

新冠疫情爆发以来，中国政府受到国际社会广泛质疑，舆论认为疫情初期中共应对不力，让全球错过最好的预防时机。

在美国大选的大背景下，特朗普政府也因对疫情处置不力一直承受巨大的压力。像莫斯科一样，美国也未将疫苗研发与航空竞争的思路分开，将疫苗命名为“曲速”（Warp Speed），灵感源于电影《星际迷航》。

如果英国成功自产疫苗将提振首相约翰逊政府的威望和信心，英国政府也因抗疫不力广受批评。英国卫生部长汉考克说，“英国继续引领世界”疫苗开发。与其他国家一样，英国也通过签订合同购买他国疫苗以防万一。但这引起人们对这场疫苗竞赛的其它担忧。

疫苗民族主义

波利基说：“西方国家肯定存在疫苗民族主义，在美国和英国的呈现形式是政府垄断大量初始疫苗供应。”

当然在新冠病毒抬头之前，民族主义就在上升。但是大流行加速了这种民族主义。

最初急于购买呼吸机和个人防护设备的国家在机场用现金互相竞争，这突显了对外国供应的依赖，并刺激国内生产能力的提高。

对于所有有关在国际上分发疫苗的说法，最先开发出来的人可能能确保他们有优先权来挽救生命并推动经济发展。同样，政府未能确保供应会导致公众愤怒和有关执政能力的担忧。

世卫组织负责人于8月18日再次呼吁富裕国家加入一项全球计划：与穷国共享疫苗。谭德塞说：“我们要防止疫苗民族主义。”

各国也可能倾向于通过外交手段向其他国家提供疫苗，通过”疫苗外交“以求获得好感和建立国际支持。

波利基认为：“每个有早期疫苗供应的政府最终都会将其中一些疫苗用于外交”。

然而，率先上市并不一定意味着疫苗将是最有效的，专家警告说，这不是一场只有一个获胜者或终点的比赛。这意味着在研发和供应疫苗方面的竞争可能才刚刚开始。

新冠疫情：疫苗研发竞赛中的抄近路、耍阴招和民族主义 - BBC News 中文

在这场竞赛中“疫苗民族主义”加剧，有的国家被指走捷径、从事间谍活动、失去道德约束的冒险和嫉妒他国。

www.bbc.com

 

[lindamy]

3 hr 54 min ago
US pharma giant extends Covid-19 vaccine trials to two more Latin American countries
From CNN's Tim Lister

People walk in Santiago, Chile, on August 17. Martin Bernetti/AFP/Getty Images

US company Johnson & Johnson has said it will extend trials of its vaccine candidate against Covid-19 to Chile and Argentina.

The vaccine will undergo Phase 3 trials in eight countries altogether, involving some 60,000 adult volunteers. The participation of Brazil, Colombia, Peru and Mexico had already been announced.

"This study is scheduled for September, subject to review by the health authority," the company said in a statement.

The countries have been chosen because they have some of the highest infection rates worldwide.

"The current prevalence of the disease, the demographics of the population and the requirements of the health authorities were taken into account to ensure that the study can be carried out properly and provide relevant data," the company said.

The study will be coordinated by Johnson & Johnson’s pharmaceutical subsidiary Janssen.

In Chile, the trial will be coordinated by the University of Chile’s School of Medicine. Miguel O’Ryan, Professor of Microbiology at the School, told Reuters that government approval was still needed for the trial, but it could begin within three weeks of the vaccine being delivered. O’Ryan said the school was prepared to recruit up to 1,000 people for the study.

Colombian President Ivan Duque said earlier this week that his government had also signed an agreement with Johnson & Johnson for Phase 3 trials.

Last week, Brazil’s regulatory authority Anvisa approved human clinical trials for the vaccine being developed by Johnson & Johnson.