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%, 100% 不会重症。没血栓。年产5亿剂

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巴基斯坦浪费10000剂康熙诺。
罪孽啊!

10,000 doses of CanSino coronavirus vaccine wasting away at Karachi warehouse​

Health
M. Waqar Bhatti
April 17, 2021
COVID-19 vaccines were to be supplied to AKU in Karachi, Shaukat Khanum Hospital, Lahore and Shifa hospital, Islamabad
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  • 10,000 doses of CanSino vaccine gathering dust in Karachi.
  • The single-dose Convidecia vaccine was imported by private company AJM Limited in Pakistan.
  • National Health Services official blames DRAP for delay in release of coronavirus vaccine consignment.




KARACHI: As many as 10,000 doses of the CanSinoBio coronavirus vaccine developed by China are lying useless at a warehouse in Karachi for the last 10 days as the Drug Regulatory Authority of Pakistan awaits approval to release the vaccines.
The single-dose Convidecia vaccine was imported by private company AJM Limited in Pakistan.
“This shipment was to be supplied to three hospitals in the country, but it has not yet been released by the DRAP due to red-tapism,” an official of the National Health Services, Regulations and Coordination was quoted as saying by The News.
Read more:Pakistan receives first shipment of 60,000 single-dose CanSino coronavirus vaccines
Pakistan had granted emergency use authorisation to China’s CanSino Biologics Inc’s COVID-19 vaccine in February, 2021 following its successful trials at various health facilities in Karachi, Lahore and Islamabad.
The federal government also purchased 60,000 doses of the Chinese vaccine last month, which are currently being used to inoculate the elderly and disabled.
So far, Pakistan has vaccinated 1.4 million of its population - mostly with China’s Sinopharm vaccine - while 20,000 people have so far been inoculated with privately imported Sputnik V vaccine, officials said.
They added that at least 30,000 people have also been given CanSino’s Convidecia vaccine at the government's adult vaccination centres.

National health services blames DRAP​

The National Health Services official blamed DRAP for the delay in release of the coronavirus vaccine consignment and said it did the same when 50,000 doses of Russian vaccine Sputnik V arrived in the country and remained in cold storage for over a month due to controversy over its pricing.
Read more:Pakistan okays emergency use of third Chinese vaccine
“As it (COVID-19 vaccine) is a biological product, it needs testing and approval by the technical director of the DRAP. There are some other documentary requirements, which must be met for the release of biological products but COVID-19 is an emergency and vaccine should not be kept even for an hour as it can result in loss of precious lives,” the official said.

'Holding 10,000 coronavirus vaccine doses is unfortunate'​

An official of the AJM Pharma Private Limited confirmed that the first shipment of 10,000 doses of China’s Convidecia vaccine had arrived at Karachi airport in the first week of April, 2021 but since then, it had not been released to them for its supply to hospitals in Karachi, Lahore and Islamabad.
Read more: A doctor’s guide for the elderly before getting a COVID-19 vaccine
“CanSino Biologics Inc’s single dose is the most suitable vaccine for Pakistan as its trials were held in three major cities of Pakistan where over 15,000 people were recruited for these trials. At a time when Pakistan desperately need this vaccine, holding 10,000 doses of this precious shipment is unfortunate,” the AJM official said.
The vaccines were to be supplied to Aga Khan University Hospital, Karachi, Shaukat Khanum Hospital in Lahore and Shifa International Hospital, Islamabad.
 

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康希诺生物董事长宇学峰:看好可吸入疫苗前景 产能充足可供全球使用​


央广网04-20 14:40
央广网北京4月20日消息(记者 马可佳)4月19日,在博鳌亚洲论坛2021年年会上,康希诺生物股份公司(下称“康希诺生物”,688185.SH,6185.HK)董事长、首席执行官宇学峰就疫苗安全性、保护率等相关问题接受了记者群访。
54d969fcde2943369b96795a254b6af5.png

(康希诺生物董事长、首席执行官宇学峰)
康希诺生物股份公司与军事科学院军事医学研究院生物工程研究所陈薇院士团队联合研发的重组新型冠状病毒疫苗(5型腺病毒载体)已于2月25日获得国家药品监督管理局批准附条件上市,商品名为克威莎。目前已在中国云南省边境地区、墨西哥、巴基斯坦、智利等地开始接种。
以下为央广网记者对宇学峰当天访谈观点的梳理。
关于疫苗接种和强化时间
记者:强生新冠疫苗出现6例罕见血栓案例,会让大家产生恐慌,您觉得如何让民众更接受去打疫苗这件事情,需要各方什么样的努力?
宇学峰:疫苗犹豫的问题是全世界都存在的。人们对科学的理解问题、个人的担心,各种因素都有。对于大多数人来说,还是能意识到疫苗的价值,大家希望疫苗都是百分之百安全,客观上人跟人的免疫体系都有差异,还有免疫缺陷,疫苗出现一些意外或者是风险,永远是存在的,不是说打疫苗每个人百分之百都安全。
但是打疫苗保护的是公众,我们要承担个人的责任,也要承担公众的社会责任,这一点特别要注意,因为只有全民接种或者大多数人接种,疾病的流行才能控制住,我们不光是为自己,还要为周边的人。哪个地方没打疫苗,一定会传过来的,感染新冠的风险远远高于打疫苗的风险。
记者:越晚打疫苗对个人的保护率越低?
宇学峰:对于流行病来说越早保护越好,变异有些差异,首先大家要清晰认识:变异不等于没有保护,彻底变了就是另外一个物种了,多少是有些保护的。
另外,我们作为疫苗研发单位也在随时地跟踪观察,是不是需要针对变异株研发新的疫苗,从现在来看为什么会变异?因为流行太广泛,任何生命体包括我们在座的每个人,每一个细胞都有百万分之一的变异率,这是生物学的规律,这是正常的。病毒变异率更高一点,因为缺少修正机制,我们越早把疫情控制住变异就越小,怎么控制疫情?需要大家去接种预防,使用疫苗把流行早日的控制住,这是大家要理解的一个问题。
记者:现在国内的疫苗有好多种,选择什么季节打疫苗更好?比如冬天高发期是否更有效?
宇学峰:中国上市的每一种疫苗大家都可以选择。什么季节打疫苗,不用去太担心,因为人都是恒温动物,不管什么季节疫苗进到人体都是特定的温度下起作用。疫苗在任何季节都可以使用。
疫苗保护期有多长?实际上在打完以后,抗体滴度快慢和个体、及疫苗的特性有关。效率对每种病毒不一样,比如乙肝疫苗打完以后终身免疫;百日咳、白喉在国外的常规做法是每10年要强化一次;流感疫苗每一年都要打。对于新冠疫苗,具体情况还不知道,我们也在研究。
记者:强化针的情况分享一下?
宇学峰:我们的初免程序不是多针的,打一针就能够达到需要的免疫效果,经过了若干月甚至一年以后会是什么状态,是不是应该再强化一下,这是我们现在正在研究的。比如说我们去年1月份-3月份在武汉的一批临床一期的志愿者,6个月以后回来做了一些强化,我们看到6个月以后再给(接种)一针疫苗的话,抗体滴度和细胞免疫强度都能提高10倍以上,再衰减周期会更长,保护更好。这是我们现在有的数据。后续有很多的工作,是一个持续进行的过程。
记者:半年之后是不是持续还得继续打疫苗?
宇学峰:我们最早的临床是去年3月份开始的,到现在一年多一点。至于其他的疫苗打半年以后是否要强化我不太清楚这个说法。
关于疫苗保护率和安全性
记者:西方媒体质疑中国疫苗保护率低的问题您怎么看?
宇学峰:疫苗保护率可接受的范围,WHO有标准答案,50%以上,我们上市的疫苗都能达到这个标准。
我们看一个疫苗是不是可使用,不仅仅要看保护率。首先大家要清晰,预防生病和预防传染是两个概念。我们可以看到所有的中国疫苗在重症保护上面都是相对比例高的。将近70%的保护率,14天就可以做到。重症保护率95%以上,哪怕感染了新冠病毒,也像得了正常的头疼感冒一样,不会有重症。
疫苗安全性,我相信在中国这么大范围的接种量条件下,应该出现的副作用应该已经看到了。康希诺生物的疫苗已在全球范围内拥有超过百万级的接种量,我们在和全球的合作伙伴紧密地跟踪这些受试者,包括接种者后期的状态。目前来说我们并没有发现和疫苗相关的严重不良反应、不良事件。
比如说局部的疼痛,稍微有点疲劳,发烧(等反应)是正常的,因为这个疫苗的作用机制我们强调的是体液免疫和细胞免疫两重免疫,尤其是细胞免疫刺激形成一些细胞因子,炎性因子会让人感觉到发烧,这是人体正常抗病毒的一个机制。大家得了流感发烧是人体在抗病毒感染的过程。
记者:一种观点认为中国的疫苗接种率不高,对于现在的情况您怎么看?有哪些建议?另外康希诺生物的产品覆盖多少群体?
宇学峰:有两个概念要澄清,接种率和接种量不一样,美国和我们接种的量差不多,但是美国的人口比咱少好几倍,所以接种率会比我们高很多。
对于病毒变异问题
记者:康希诺生物对于国外的变异病毒这一块有没有一些研究或者是做法?
宇学峰:我们一直在研究,一直关注变异株,从目前进行的中和抗体交叉实验结果来看,康希诺生物单针新冠疫苗对境内外流行的新冠病毒株均有保护作用。
记者:市场上的疫苗种类繁多,国内的、国际的,如果接种一种疫苗以后又接种另外一种会怎样?
宇学峰:科学上讲不应该有太大的问题,因为大多数疫苗,除了灭活疫苗是整个抗新冠的抗体,可是抗体到底有些什么样的正作用、副作用,不知道。剩下的都是刺激蛋白。无非是刺激体液免疫还是细胞免疫,还是两种都刺激。
但是从药政管理的角度上讲混合接种是需要有临床数据支持的。要用临床试验来证明它的安全性和有效性,我们也在准备未来进行这样的实验。
记者:康希诺生物的疫苗的优势是什么?
宇学峰:一针有效这是很大的优势,现在各个省市都在全力推进疫苗接种,都要打两针甚至还有三针的,工作量就会大很多,对地方财政也是负担,人员的费用、误工费用、耗材费用……所以打一针就保护大家了,医疗人员的负担也轻了,能够起到很好的保护作用。所以一针有效是一个优势。
第二个优势是反应快,我们三期4万多人的临床数据说明14天就可以起效果。尤其在大疫情爆发的时候,打了一针马上就管用,对于疫情控制是非常好的手段。云南发生疫情康希诺生物单针新冠疫苗抵达后,主要在边境的一个县全民接种。
我们的疫苗刺激的是双重免疫体系,人体有体液免疫,还有细胞免疫,有些病毒躲在细胞里面不出来,我们可以用免疫识别把它干掉,而且有长期的细胞记忆,这个也是优势之一。
我们现在正在开发的黏膜免疫(可吸入疫苗),可提供三重保护,新冠病毒是通过呼吸道黏膜途径进去的,我们把第一道防线设在感染人的起始点上,我相信保护效果将是非常好的。
对于可吸入疫苗研发
记者:普通的接种疫苗相比可吸入疫苗,哪个保护效果更好?
宇学峰:(单针疫苗)我们天津的厂房生产2-3亿剂,可吸入(疫苗)至少10个亿剂的产能,这个对于大规模使用疫苗有非常好的帮助。
另外,该疫苗诱导体液免疫、细胞免疫、黏膜免疫三重保护,效果更好,使用更便捷。我们也看到,现在全球注射器紧张,可吸入疫苗用个杯子、有个吸管一吸就进去了,方便大面积的接种,尤其在大疫情爆发条件下。
记者:可吸入疫苗的起效时间和保护周期有变化吗?
宇学峰:我们正在研究,刚刚开始临床。我们现在做的一些研究表明,吸入以后在人体的细胞免疫和抗体免疫只要用1/5的剂量能达到和打一针同样的效果。
记者:可吸入疫苗什么时候会投放市场?
宇学峰:现在刚刚开始临床试验,我对试验结果很有信心。
关于产能和疫情结束
记者:现有的产能多少,今年有一个目标吗?
宇学峰:我们产能是在逐渐放量,天津2-3亿剂,已经开始生产。我们和上药合作的一家公司叫上药康希诺,这个建设也在紧锣密鼓之中,未来两三个月投产,规模和天津规模一样,也是2-3亿剂,这样的话我们是5亿剂的年产能。
如果吸入给药的话可以节约很多,保守估计20%的用量,可以达到25亿(剂),全球不到80亿人两年下来差不多接种一遍,产能大家不用太担心。
记者:是否代表着疫情即将过去的时期已经不远了?
宇学峰:我们希望大流行尽快过去,去年2月份在世卫有关新冠研发的会议上,有专家明确地指出新冠这个病毒会和人类长期共存,因为很难把这么强感染力的病毒在人群中消灭掉。好像全球麻疹疫苗,接种了多少年了,全球仍时不时有爆发,包括在中国也时不时有爆发。
(新冠病毒)我觉得要有一个打持久战的准备。甚至成为一个常规流行病。
 

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1 hr 32 min ago

More than 2.7 million Covid-19 vaccine doses administered in Pakistan​

From CNN's Sophia Saifi in Islamabad
A health worker inoculates a man with a dose of the Sinopharm vaccine at a vaccination center, in Rawalpndi, Pakistan, on May 3.
A health worker inoculates a man with a dose of the Sinopharm vaccine at a vaccination center, in Rawalpndi, Pakistan, on May 3. Aamir Qureshi/AFP/Getty Images

Pakistan has administered more than 2.7 million Covid-19 vaccine doses, according to a tweet by the country’s National Command and Operation Centre on Coronavirus (NCOC).

On Monday, Pakistan opened up vaccinations for citizens aged 40 and above. More than 164,000 vaccine doses were administered on Monday alone, according to Asad Umar, the head of the NCOC.
The Pakistani Ministry of Health says the country has currently signed deals for 30 million vaccine doses. Last week, the country said it had received 2,560,000 doses and is expecting 19 million more doses by the end of June.

Separately on Monday, Pakistan’s top health official, Dr Faisal Sultan, announced that the government plans to vaccinate 70 million people by the end of the year.

He said that agreements are underway with China to ensure that the country’s National Institute of Health will be able to produce three million doses per month of the Chinese vaccine CanSino, which will “significantly reduce” Pakistan’s vaccine dependence on other countries.
 

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1 hr 32 min ago

More than 2.7 million Covid-19 vaccine doses administered in Pakistan​

From CNN's Sophia Saifi in Islamabad
A health worker inoculates a man with a dose of the Sinopharm vaccine at a vaccination center, in Rawalpndi, Pakistan, on May 3.
A health worker inoculates a man with a dose of the Sinopharm vaccine at a vaccination center, in Rawalpndi, Pakistan, on May 3. Aamir Qureshi/AFP/Getty Images

Pakistan has administered more than 2.7 million Covid-19 vaccine doses, according to a tweet by the country’s National Command and Operation Centre on Coronavirus (NCOC).

On Monday, Pakistan opened up vaccinations for citizens aged 40 and above. More than 164,000 vaccine doses were administered on Monday alone, according to Asad Umar, the head of the NCOC.
The Pakistani Ministry of Health says the country has currently signed deals for 30 million vaccine doses. Last week, the country said it had received 2,560,000 doses and is expecting 19 million more doses by the end of June.

Separately on Monday, Pakistan’s top health official, Dr Faisal Sultan, announced that the government plans to vaccinate 70 million people by the end of the year.

He said that agreements are underway with China to ensure that the country’s National Institute of Health will be able to produce three million doses per month of the Chinese vaccine CanSino, which will “significantly reduce” Pakistan’s vaccine dependence on other countries.



对印度变异有没有效果,有待进一步观察。
 
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