中国第三款 CanSino 陈薇主导的腺病毒单针疫苗。第三期数据(2月8日):总效力 74.8%, 没血栓。巴基斯坦代工厂启动

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这款疫苗当初如果跟加拿大合作的话,这里肯定会说是加拿大技术,否则中国人做不了。
 

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德国之声中文网
继中国国药集团和科兴中维的两款灭活疫苗公布三期临床数据后,中国军事科学院与康希诺生物合作研发的腺病毒载体疫苗(Ad5-nCoV)的数据也于2月8日出炉。该疫苗与之前两款中国疫苗采用的是不同的技术路线。

2月10日康希诺生物宣布,这款重组新型冠状病毒疫苗在墨西哥获得了紧急使用授权,用于18岁及以上成人,商品名为"克威莎"。

据路透社2月8日援引巴基斯坦卫生部部长报道称,一项对全球试验的中期分析显示,中国康希诺生物开发的新冠疫苗在预防严重疾病方面的有效性为90.98%。巴基斯坦卫生部长补充说,在巴基斯坦的亚组中,康希诺生物的疫苗在预防有症状病例方面的有效性为74.8%,在预防严重疾病方面的有效性为100%。

目前全球发布三期数据的单针疫苗只有美国强生公司的腺病毒载体疫苗(Ad26.COV2.S)和康希诺的这款。俄罗斯的"卫星V"和英国的阿斯利康也是采用该技术,但需要注射两针。强生公司的Ad26.COV2.S疫苗在预防中至重度新冠肺炎方面的有效性为66%。

据中国官媒《环球时报》报道, "Ad5-nCoV在全球的三期临床试验数据显示,单针接种疫苗28天后,疫苗对重症新冠肺炎的保护效力为90.98%,总体保护效力为65.7%。"报道指出,这款中国疫苗的三期临床试验在5个国家、对4万余受试者进行了接种,分别为墨西哥、俄罗斯、巴基斯坦、阿根廷和智利。

路透社的报道也提到,巴基斯坦卫生部长之前曾表示,根据与康希诺生物达成的协议,该国可以获得"数千万剂"康希诺生物疫苗。

王凡/达扬(路透社等)
 

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NEWS

Days after announcing deal, Ottawa learned China blocked CanSino’s vaccine shipment​

By Charlie Pinkerton. Published on Jan 26, 2021 12:57pm
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The Chinese embassy in Ottawa (Jolson Lim/iPolitics)

The federal government found out that the Chinese government was interfering with Canada’s plan to test and possibly produce a COVID-19 vaccine made by a Chinese company just days after Prime Minister Justin Trudeau announced the deal, according to newly released government documents.

The agreement between the Canadian government and CanSino Biologics Inc. would have made the latter the first company to conduct clinical trials for a COVID vaccine in Canada. It was also the first deal through which Canada could have secured a vaccine supply. It wasn’t until three months later — and after Trudeau announced additional vaccine deals with two other pharmaceutical companies — that his government conceded that its deal with CanSino was dead.
READ MORE: Canada-bound vaccine blocked by China’s customs was created with Canadian tech

The National Research Council (NRC), the federal government’s scientific research organization, signed a deal with CanSino on May 6, 2020, to conduct Phase 1 and 2 clinical trials of its COVID shot, according to an NRC document that was tabled in the House of Commons on Monday.
Trials were meant to take place at Dalhousie University’s Canadian Center for Vaccinology.
CanSino’s product, called Ad5-nCoV, was considered one of the world’s top vaccine candidates at the time. It was made with the help of the Chinese military’s research arm.

“Under this agreement, CanSino was to provide candidate vaccine doses and transfer their vaccine technology, free of charge, for Phase 1 and 2 clinical trials in Canada, and grant the NRC a non-exclusive right to use, produce, and reproduce the vaccine for emergency pandemic use,” the NRC said in the response to a question on the House’s order paper from Conservative Health critic Michelle Rempel Garner.

Neither CanSino nor the Chinese government got any money from the Canadian government through the deal, the NRC said. Expecting more vaccines to be produced, Ottawa committed $44 million to ensure that the NRC’s facilities in Montreal met manufacturing standards.

On May 12, the NRC announced its plans to work with CanSino. Four days later, Trudeau promoted the partnership at one of his then-daily press briefings.
“If these vaccine trials are successful, we can produce and distribute it right here at home,” Trudeau said on May 16. “Research and development take time and must be done right, but this is encouraging news.”

Dr. Scott Halperin, director of Dalhousie’s vaccinology centre, told iPolitics around the same time that he hoped clinical trials would be approved “within the next week or two.”
READ MORE: Clinical trials of Chinese vaccine similar to Ebola immunizer in Canada to begin in weeks
On May 19, the federal government learned that the shipments of the vaccine candidate were being held by China’s customs agency at Beijing Capital International Airport, according to documents tabled by Global Affairs Canada.

China’s State Council, the country’s cabinet, refused to issue the approval letter allowing the vaccine to ship to Canada. Around the same time, Chinese-made vaccine candidates were permitted to ship to other countries for trials similar to those CanSino had agreed to with the NRC.
Screen-Shot-2021-01-26-at-12.16.44-PM-600x185.png
A screenshot of a document from Global Affairs Canada tabled in the House of Commons on Jan. 25
It wasn’t until July 6 that the vaccine’s holdup was made public, when iPolitics reported that Halperin told a Commons committee that the Canadian Center for Vaccinology hadn’t received CanSino’s initial shipment.

On July 9, iPolitics reported for the first time that China’s customs agency was responsible for stalling the shipment.
READ MORE: Vaccine promised for human trials in Canada held up by Chinese customs

While the government originally had high hopes for CanSino’s vaccine, those hopes fizzled after more data about the vaccine were made public, the NRC said.
“The Vaccine Task Force had originally ranked the CanSino Biologics vaccine candidate among the most promising globally. (Its) recommendation was subsequently revised, based on (its) analysis of additional clinical-trial data,” the NRC said.

The task force made that revision in July, John Power told iPolitics in a statement on Tuesday.

Power is the spokesman for François-Philippe Champagne, minister of Innovation, Science and Industry, the department that oversees the NRC.
On Aug. 5, Procurement Minister Anita Anand announced that the government had agreed to buy vaccines from Pfizer and Moderna. Their shots have since been approved by Health Canada and are being distributed across Canada.
“Due to lengthy delays in the shipment of the vaccine doses to Canada, the fact that CanSino’s candidate had already entered advanced testing in other countries, and the new clinical-trial data that had emerged from other
jurisdictions, it was decided in late August that the opportunity to conduct clinical trials in Canada for Ad5-nCoV had passed, and the government decided to focus on more promising candidates,” the NRC said.

The federal government and CanSino abandoned their partnership in late August.

CanSino is now running Phase 3 trials for Ad5-nCoV in several countries, including Pakistan, Russia, Mexico, and Chile. It hasn’t yet published final phase findings. China’s military approved the Ad5-nCoV for its soldiers on June 25. In November, the company’s chief executive said as many as 50,000 people had received it.

Screen-Shot-2021-01-26-at-12.22.07-PM-557x600.png
A screenshot of a document from the National Research Council that was tabled in the House of Commons on Jan. 25, 2021.

The failed vaccine collaboration came in the middle of diplomatic tensions between Canada and China, which continue.

Two Canadians, Michael Kovrig and Michael Spavor, have been in jail in China for more than two years. Officials from both countries’ governments have linked their imprisonment to the arrest of Huawei executive Meng Wanzhou, whose trial in Canada will determine whether she’s extradited to the U.S. to face charges of violating American trade sanctions against Iran.


 

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国内首个单针接种的新冠疫苗来了!安全性、有效性如何?白岩松专访陈薇院士​

央视新闻

25日,陈薇团队研发的我国首个腺病毒载体新冠疫苗获批附条件上市,这也是全球第一个进入临床的新冠疫苗。研究员介绍,该疫苗是目前国家批准上市的新冠疫苗中,唯一可采用单针接种程序的疫苗。单针接种14天后即可获得良好保护效果,且可在2℃—8℃的条件下运输保存。

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疫苗的安全性怎么样?公众又该如何选择?26日,白岩松专访中国工程院院士陈薇,就疫苗研发过程、保护效力等问题,进行分析和解答。

疫苗年产能达多少?
陈薇:
我们做的基因工程疫苗最大的特点就是能够快速规模化生产。从数据来看,年产能今年达到5个亿是没有问题的。这里有一个前提,因为是打一针,5亿剂相当于是5亿人的接种,不是2.5亿人的接种。

疫苗有效率有多大?
陈薇:
疫苗的最大作用就是防止重症,所以一个疫苗能够减少重症的发病率,就是减少死亡率。我们在巴基斯坦重症保护率能达到全部保护,在全球所有人里面,重症保护率能达到90%以上,这是一个可喜的数据。

2020年3月16日,重组新冠疫苗(腺病毒载体)在武汉启动Ⅰ期临床试验,是全球首个进入临床研究阶段的新冠候选疫苗;同年4月12日,该疫苗率先进入Ⅱ期临床试验。2020年9月22日,该疫苗在巴基斯坦、俄罗斯等五个国家的78家临床研究中心开展了全球多中心Ⅲ期临床研究,共完成了近5万名受试者的接种。

Image


疫苗安全性如何?有无不良反应?
陈薇:
到现在为止,接种的人群包括极端环境下的人群,没有发现跟疫苗相关的严重不良反应,也没有发现跟其他疫苗有不一样的特别特殊的不良反应。

疫苗保护期有多久?
陈薇:
到目前为止6个月的数据是有的,6个月中你可以不用接种。如果6个月以后疫情还没有结束,我们也做了6个月以后的加强针,再打一针,免疫反应可以有10倍、20倍的增高。根据数据,我们推测新冠也会在两针之后,达到两年的免疫持久性。

对接种年龄有何要求?现有附条件上市的疫苗都有年龄限制,18岁之下、60岁之上人群不能接种。陈薇团队所研发的疫苗是否有可能更快地普及整个人群?
陈薇:在二期临床试验(2020年4月)时,我们就放开了年龄上限。因为55岁或60岁以上年长者恰好是重症发生率比较高的一个群体,当时最年长的志愿者是84岁的熊先生,因为是随机双盲,后来揭盲时发现他的抗体是阳性,这带给大家很大的信心。此外,6到18岁的临床已经做完了,安全性数据我们是有的,药监局还在审核。

2℃—8℃的运输条件是如何考虑的?
陈薇:
国外有些疫苗需-70℃保存,这在基础设施不全的地方很难普及。但2℃—8℃仍需冷链,未来希望通过学科交叉做到非冷链。我做疫苗有个理想,叫“双非”,非注射、非冷链。目前,我们已经在全世界做完临床试验了,这些数据马上也会公布。

全球多地出现新冠病毒变异毒株,是否影响疫苗效力?
陈薇:
疫苗上市后我们会对安全性做长期跟踪,也会跟踪疫苗对新出现变异株的有效率。我们在分析变异株的数据,用实验验证它们对现有疫苗的交叉反应作用。也早已启动针对变异株的疫苗研发,这个疫苗不一定用得上,但宁愿备而不用,不能用而不备。

针对目前国内已研发出的两种新冠疫苗,应如何选择?
陈薇:
到目前为止两大类疫苗,一类是灭活疫苗,一类是腺病毒载体疫苗。每个疫苗的安全性、有效性都是有一定数据支撑的。如果你想打的次数少一点,想更快产生免疫反应,14天就有60%多的保护率,或者你打一针就要出国或执行任务,腺病毒载体新冠疫苗是首选。

中国的疫苗研发在世界上处于什么水平?
陈薇:第一方阵,毋庸置疑,
这是没有几个国家能做到的。我们既不夜郎自大,也绝不妄自菲薄。学习别人更多的长处,做更好、更安全的疫苗,但在这个过程中,我们一定要有科技自信。
 

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2021.02.27 18:52 GMT+8

China approves homegrown single-dose vaccine CanSino​

Updated 2021.02.27 18:52 GMT+8

CGTN

0ea497b0ba554d3f80c854e1779f3317.jpg


Unlike most of the other vaccines, the jabs of the vaccine CanSino requires only one shot. Researchers say its efficacy rate can reach 68 percent. And it doesn't need to be kept at a really low temperature. The single-dose CanSino vaccine is developed by the military scientist Chen Wei's team, and Chen says it appears highly effective.
 

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中国是很想给加拿大疫苗的,可是首先加拿大得释放梦呀。释放了梦,什么都好说。
 

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中国是很想给加拿大疫苗的,可是首先加拿大得释放梦呀。释放了梦,什么都好说。


反对党还在挖坑。
无解。
 

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反对党还在挖坑。
无解。
小土豆还在拉帮结派,有个毛用。他真的不了解中国。你不放人,拉再说人都是空的。想办法叫美国撤诉。大家皆大欢喜。美国是给加拿大挖坑。就是想要搞坏中加关系。
 

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疫苗年产能达多少?
陈薇:
我们做的基因工程疫苗最大的特点就是能够快速规模化生产。从数据来看,年产能今年达到5个亿是没有问题的。这里有一个前提,因为是打一针,5亿剂相当于是5亿人的接种,不是2.5亿人的接种。

这个数量卖给加拿大1亿完全没问题。
 

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疫苗年产能达多少?
陈薇:
我们做的基因工程疫苗最大的特点就是能够快速规模化生产。从数据来看,年产能今年达到5个亿是没有问题的。这里有一个前提,因为是打一针,5亿剂相当于是5亿人的接种,不是2.5亿人的接种。

这个数量卖给加拿大1亿完全没问题。
加拿大被美国压着,不敢问中国。而且自己也不好意思,梦都没有放,他怎么好意思开口问中国要疫苗?
 

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小土豆还在拉帮结派,有个毛用。他真的不了解中国。你不放人,拉再说人都是空的。想办法叫美国撤诉。大家皆大欢喜。美国是给加拿大挖坑。就是想要搞坏中加关系。

你必须在土豆的角度考虑,不是在抗疫上考虑。

如果为了疫苗,土豆在孟晚舟上让步,加拿大人会怎么说?对土豆的政治生命是什么影响?
 

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如果为了疫苗,土豆在孟晚舟上让步,加拿大人会怎么说?对土豆的政治生命是什么影响?
这个可以操作。表面上是用梦换两个麦克,实际上连同疫苗一起。加拿大民众是赞同用梦换麦克的。
 

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这个可以操作。表面上是用梦换两个麦克,实际上连同疫苗一起。加拿大民众是赞同用梦换麦克的。



加拿大人民说,人不可以交易。
 
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