蒲公英 - 制药技术的传播者 GMP理论的实践者

搜索
查看: 7148|回复: 16
收起左侧

[社会广角] 刚果最近ebola疫情爆发,为什么不用我国批准的埃博拉疫苗??

[复制链接]
药士
发表于 2018-5-20 16:14:40 | 显示全部楼层 |阅读模式

欢迎您注册蒲公英

您需要 登录 才可以下载或查看,没有帐号?立即注册

x
本帖最后由 beiwei5du 于 2018-5-20 16:23 编辑

刚果最近ebola疫情爆发,为什么不用我国批准的埃博拉疫苗??而以同情使用的方式使用merck的未批准的埃博拉疫苗???

国产重组埃博拉疫苗获得新药注册批准:首创冻干剂型
WHO readies to test Merck’s experimental Ebola vaccine in Congo outbreak
China approves domestic Ebola vaccine developed from recent outbreak
The vaccine differs from programs at GSK and Merck because those companies' vaccines are developed to express the glycoprotein of the Ebola virus identified during the disease’s discovery back in 1976. CanSino says the two virus types are very similar, but slight differences could allow its shot to provide better protection in the real world.
In a 500-participant phase 2 trial in Sierra Leone, the results of which were published earlier this year in The Lancet, the vaccine elicited strong antibody responses in volunteers within 28 days. Researchers noted that the responses, though still existent, decreased significantly at day 168, a finding the team said is consistent with previous tests on rVSV-ZEBOV in Africa and Europe.
In a related commentary published alongside the Ad5-EBOV study results, two experts from the Netherlands expressed concerns about the “durability of protection when implementing mass vaccination campaigns in future outbreak settings in Africa.” CanSino, in a written response to FiercePharma, said the product is positioned for emergency use for now; therefore, it's currently not focused on long-term efficacy. The company didn't rule out the possibility for implementing a booster shot in the future.
A recent phase 2 study conducted by a U.S.-Liberia partnership showed that responses to Merck’s and GSK’s shots also peaked after a month, and that most recipients of the two shots still had an antibody response at one year.



回复

使用道具 举报

药徒
发表于 2018-5-20 20:06:36 | 显示全部楼层
英文能力不行,看着不太懂,但是汉字看懂了,是否可以理解,即使在刚果,也不相信我们的药?楼主能否顺便普及一下,什么叫“同情性使用啊”
回复

使用道具 举报

发表于 2018-5-20 20:43:04 来自手机 | 显示全部楼层
英文太差,直接没懂
回复

使用道具 举报

药士
发表于 2018-5-20 23:48:15 | 显示全部楼层
对呀,为什么不用我国批准的埃博拉疫苗?
回复

使用道具 举报

药徒
发表于 2018-5-21 08:44:22 | 显示全部楼层
英文没看懂,从中文感觉我们国家的药真有那么次么?连人家没批准的药都比不过?
回复

使用道具 举报

药士
 楼主| 发表于 2018-5-21 09:29:05 | 显示全部楼层
wcy123qwe 发表于 2018-5-21 08:44
英文没看懂,从中文感觉我们国家的药真有那么次么?连人家没批准的药都比不过?

不太清楚是什么原因,merck的应该是针对于1976年病毒型,康希诺应该是针对于2014年变异的病毒型。但是下面有句话却说:The vaccine differs from programs at GSK and Merck because those companies' vaccines are developed to express the glycoprotein of the Ebola virus identified during the disease’s discovery back in 1976. CanSino says the two virus types are very similar, but slight differences could allow its shot to provide better protection in the real world.

这种疫苗一般是国家储备型,不知道现在康希诺是够有了商业化生产???以及是否除了国内储备外,其他国家是否有接受国家储备??
康希诺的埃博拉疫苗是通过加速审评(跳过临床3期试验)直接被批准的,而现在merck的药品相当于在非洲field test做相应的三期临床。



点评

用谁生产的疫苗,估计是WHO决定的哈?你上面WHO的链接里有下面2段话 There are a number of experimental Ebola vaccines at various stages in development, but the Merck vaccine is the only one to date tha  详情 回复 发表于 2018-5-25 05:31
也许主要区别在这里 国产的 Researchers noted that the responses, though still existent, decreased significantly at day 168, a finding the team said is consistent with previous tests on rVSV-  详情 回复 发表于 2018-5-24 22:05
谢谢解惑,感觉还是有点制药界里面弱国的意思  详情 回复 发表于 2018-5-21 09:37
回复

使用道具 举报

药徒
发表于 2018-5-21 09:37:58 | 显示全部楼层
beiwei5du 发表于 2018-5-21 09:29
不太清楚是什么原因,merck的应该是针对于1976年病毒型,康希诺应该是针对于2014年变异的病毒型。但是下面 ...

谢谢解惑,感觉还是有点制药界里面弱国的意思
回复

使用道具 举报

发表于 2018-5-21 14:17:02 | 显示全部楼层
翻译下:
世卫组织准备在刚果爆发中测试默克的实验性埃博拉疫苗
中国批准最近爆发的国内埃博拉疫苗。
疫苗与葛兰素史克和默克的疫苗不同,因为这些公司的疫苗是为了在1976年发现疾病时发现的埃博拉病毒的糖蛋白而研制的。CanSino说这两种病毒类型非常相似,但细微的差别可以让它在现实世界中提供更好的保护。
在今年早些时候发表在《柳叶刀》(the Lancet)上的一项针对塞拉利昂的500人参与的第二阶段试验中,疫苗在28天内引发了志愿者的强烈抗体反应。研究人员指出,虽然这种反应仍然存在,但在第168天显着下降,该研究小组认为这与以前对非洲和欧洲的rVSV-ZEBOV测试结果一致。
在与AD5 EBOV研究结果一起发表的相关评论中,来自荷兰的两位专家对“在非洲未来疫情环境下实施大规模疫苗接种活动时的保护持久性”表示担忧。anSino在对FiercePharma的书面回应中表示,产品现在定位为紧急用途;因此,因此,它目前并不注重长期疗效。该公司没有排除在未来实施助推器的可能性。
最近一项由美国-利比里亚合作进行的第2阶段研究表明,对默克和葛兰素史克的疫苗注射的反应也在一个月后达到了高峰,而且大多数注射者在一年内仍有抗体反应。
回复

使用道具 举报

药徒
发表于 2018-5-24 22:05:52 | 显示全部楼层
beiwei5du 发表于 2018-5-21 09:29
不太清楚是什么原因,merck的应该是针对于1976年病毒型,康希诺应该是针对于2014年变异的病毒型。但是下面 ...



也许主要区别在这里

国产的
Researchers noted that the responses, though still existent, decreased
significantly at day 168,
a finding the team said is consistent with previous tests on rVSV-ZEBOV in Africa and Europe.

另外那2个
A recent phase 2 study conducted by a U.S.-Liberia partnership showed that responses to Merck’s and GSK’s shots also peaked after a month, and that most recipients of the two shots still had an antibody response at one year.
回复

使用道具 举报

药徒
发表于 2018-5-24 22:20:55 | 显示全部楼层
另外,在荷兰人的评论里,提到了国产疫苗II期试验时候,好像是有“A fatal serious adverse event occurred in the high-dose vaccine group”的,这个可能也会影响决策
回复

使用道具 举报

药士
 楼主| 发表于 2018-5-24 23:24:32 | 显示全部楼层
cnosema 发表于 2018-5-24 22:05
也许主要区别在这里

国产的

可能也有这方面的考虑。
只是有点不清楚的是为什么康希诺会在2017年底走加速审评,当时的一个大环境是埃博拉病毒疫情已经控制,并不是算是很紧急的情况,国外的疫苗也是在走正常的三期。
国内那么紧急批准的目的在于什么??况且国内也没有出现相应的疫情,现在加速批准了,反而国外并不是承认,也没有使用起来,意义又何在呢??
如此加速批准,一方面可能造成阻碍了进一步研发,同时后期的有效性是否能真正保证也都存在疑问,特别是在国内的phase 4临床研究不靠谱执行的情况下(监管方监管不利+企业趋利不执行)。

点评

国内的加速审评,也许是为了尽早占有市场/名誉/舆论。具体原因,得向监管方查询了哈  详情 回复 发表于 2018-5-25 05:33
回复

使用道具 举报

药徒
发表于 2018-5-25 05:31:51 | 显示全部楼层
beiwei5du 发表于 2018-5-21 09:29
不太清楚是什么原因,merck的应该是针对于1976年病毒型,康希诺应该是针对于2014年变异的病毒型。但是下面 ...

用谁生产的疫苗,估计是WHO决定的哈?你上面WHO的链接里有下面2段话

There are a number of experimental Ebola vaccines at various stages in development, but the Merck vaccine is the only one to date that has been shown to work in people. (The others may well work but their developers haven’t yet been able to prove that with Phase 3 clinical trials.)

In a clinical trial in Guinea during the disastrous West African outbreak, the Merck vaccine was shown to be highly effective and to generate immune protection quickly — two factors that are highly desirable in a vaccine designed for outbreak response.
回复

使用道具 举报

药徒
发表于 2018-5-25 05:33:16 | 显示全部楼层
beiwei5du 发表于 2018-5-24 23:24
可能也有这方面的考虑。
只是有点不清楚的是为什么康希诺会在2017年底走加速审评,当时的一个大环境是埃 ...

国内的加速审评,也许是为了尽早占有市场/名誉/舆论。具体原因,得向监管方查询了哈

回复

使用道具 举报

药士
 楼主| 发表于 2018-5-26 15:28:12 | 显示全部楼层
Why the World Needs More Than OneEbola Vaccine

By Reuters
·        May 23, 2018
LONDON — - Inthe life-and-death race to make the first effective vaccine against Ebola, onecompany - Merck - seems bound to win.
But othersdrugmakers, such as Johnson & Johnson and GlaxoSmithKline, are also in therunning - and must stick with it even though they are unlikely to make aprofit, experts say, because the world needs more than one Ebola vaccine.
Immunisationswith Merck's VSV EBOV experimental shot began in Congo this week - a big momentin a 40-year fight against a disease that until now could only be tackled byisolation and strict hygiene.
Having this vaccine means the world isbetter placed now than it was in 2014-2016, when the haemorrhagic fever killedmore than 11,300 people in history's worst Ebola outbreak in West Africa.
Still, relyingon one potential vaccine from one company does not make sense, either in termsof ensuring resilient supply or the best protection against the virus, saysJeremy Farrar, director of the Wellcome Trust global health charity.
"It'scritical that we encourage companies to keep working on this," he toldReuters.
"Firstly,it may be that two vaccines may have very different characteristics.
"And wealso need more than one manufacturer. You can't expect one company to carry theburden of the whole production facility for an Ebola vaccine."
Ebola is afearsome disease but it is also still rare, making the potential market for anemergency vaccine highly sporadic and very likely unprofitable.
This poses a dilemma for drug companies:With no real prospect of a financial return, can they justify the investment,even when they get support from government agencies and charities.
GSK's put itsEbola vaccine work on hold after it was unable to progress its product throughclinical trials towards the end of the 2014-16 epidemic, due to the dwindlingnumber of Ebola cases. A spokesman said it is monitoring the situation.
J&J ispushing ahead. Since the big West African outbreak, the company has gone on totest its vaccine on 5,000 volunteers in 11 separate trials, confirming itssafety and ability to generate an immune response.
"We arenot doing this for a commercial purpose," said Paul Stoffels, J&J'sChief Scientific Officer told Reuters in an interview.
"If youhave technology that can help fight the most deadly virus in the world, thenyou can't stand back and not do this.
"Thereare also benefits to us. We are also learning all the time about vaccinetechnology, which has advanced our science."
COMPLEMENTARY
J&J'stwo-part vaccine - being developed with Danish biotech Bavarian Nordic - worksdifferently to Merck's and its protection, if confirmed, is expected to belonger lasting.
Merck's shot is well suited for "ringvaccination" of people in recent contact with new Ebola cases, but along-lasting option would be a good bet for healthy support workers coming into fight the crisis.
"Certainlyfrom what we know about the J&J vaccine, it could have a very complementaryuse," said Peter Salama, the World Health Organization's deputy director-generalfor emergency preparedness and response.
"It lookslike it takes a little longer to develop the immune response, but at the sametime it may last a lot longer ... it could be an ideal vaccine for healthcareworkers, for example, who you could proactively vaccinate and know that theyare protected for 10 years or so."
One problemremains the lengthy, complex and expensive process of getting new vaccineslicensed by Western regulators, like the U.S. Food and Drug Administration(FDA).
Merck - whosevaccine was originally developed by the Public Health Agency of Canada and thenhanded to NewLink Genetics, before Merck took it on in 2014 - does not expectto be ready to seek an FDA marketing authorisation licence for VSV EBOV until2019.
This is inpart due to "unforeseen facility and engineering issues" at amanufacturing plant being built in Germany, Merck's spokeswoman Pamela Eiselesaid.
"We ...are focused on getting vaccine manufacturing on-line as quickly aspossible."
The companycould get a pay-off when the vaccine is finally licensed, in the form of an FDApriority review voucher, which can be used with another product of its choiceor sold on.
The FDA issues such vouchers for innovativedrugs or vaccines tackling neglected or rare diseases, including Ebola, andpast examples have been sold for up to $350 million (262.2 million pounds).
The onlylicensed Ebola vaccines come from separate groups in Russia and China. Theirproducts have been approved by local regulators only on the basis of limitedclinical data. An FDA licence is widely regarded as the definitive stamp ofapproval.
BEYOND EBOLA
Large drugcompanies remain the only realistic vehicles for manufacturing vaccines atscale and the problem of incentivising them to work on non-profitable diseasesin poor countries stretches beyond Ebola.
"In anyvaccine market, at some point the manufacturers assess whether its a viablemarket to continue, and they may stop," Salama told Reuters.
Sanofi, forexample, dropped development of a Zika vaccine last year, despite promisingearly clinical results, following a row over future pricing of the product,which was originally developed by U.S. Army researchers.
Such hesitancyby drug companies is going to need to be overcome, experts say, especiallysince a crowded world can expect an increasing number of deadly encounters withmicrobes.
In the past 60years, the number of new infectious diseases affecting humans has increasedfourfold and the number of outbreaks per year has more than tripled, accordingto report from the International Vaccines Task Force.
Only this week India has been hit by the brain-damagingNipah virus, killing 10 people, while Nigeria had its worst Lassa feveroutbreak on record earlier this year.
There arecurrently no vaccines for either of these, but both are on a WHO research anddevelopment priority list alongside Ebola, Zika, MERS and Crimean-Congohaemorrhagic fever.
(Reporting by Kate Kelland and BenHirschler, editing by Anna Willard)

回复

使用道具 举报

药徒
发表于 2018-5-27 08:09:09 | 显示全部楼层
几点猜测,第一,当然是口碑,默克的实力和口碑我就不解释了
第二,他们的疫苗估计都是基于非洲或者说是黑人研发,临床试验等等,直接性可能更高
第三,疫苗储备,不可能混合使用,单一量估计无法满足市场
第四,国内暂时不重视非洲市场(好像不太可能,或许是不想做免费慈善,做慈善能把公司做跨了
第五,能力所不及,这个不是默克强不强,而是我们太弱,毕竟我们自己都这么想,别人估计更甚
回复

使用道具 举报

药士
 楼主| 发表于 2018-5-27 08:14:18 | 显示全部楼层
贝多芬的画笔 发表于 2018-5-27 08:09
几点猜测,第一,当然是口碑,默克的实力和口碑我就不解释了
第二,他们的疫苗估计都是基于非洲或者说是黑 ...

Cansino一期是在国内健康人做的,二期是在非洲做的,三期减免,然后加速审评审批;
还有一个原因可能本身前期的临床数量相对比较少吧。
回复

使用道具 举报

药徒
发表于 2018-5-27 08:21:35 | 显示全部楼层
beiwei5du 发表于 2018-5-27 08:14
Cansino一期是在国内健康人做的,二期是在非洲做的,三期减免,然后加速审评审批;
还有一个原因可能本 ...

也是,这样的病毒试验,进行几年甚至几十年的临床试验都不过分
回复

使用道具 举报

您需要登录后才可以回帖 登录 | 立即注册

本版积分规则

×发帖声明
1、本站为技术交流论坛,发帖的内容具有互动属性。您在本站发布的内容:
①在无人回复的情况下,可以通过自助删帖功能随时删除(自助删帖功能关闭期间,可以联系管理员微信:8542508 处理。)
②在有人回复和讨论的情况下,主题帖和回复内容已构成一个不可分割的整体,您将不能直接删除该帖。
2、禁止发布任何涉政、涉黄赌毒及其他违反国家相关法律、法规、及本站版规的内容,详情请参阅《蒲公英论坛总版规》。
3、您在本站发表、转载的任何作品仅代表您个人观点,不代表本站观点。不要盗用有版权要求的作品,转贴请注明来源,否则文责自负。
4、请认真阅读上述条款,您发帖即代表接受上述条款。

QQ|手机版|蒲公英|ouryao|蒲公英 ( (京)-非经营性-2014-0058 京ICP证150354号 京ICP备14042168号-1 )

GMT+8, 2024-3-29 04:51

Powered by Discuz! X3.4运维单位:苏州豚鼠科技有限公司

Copyright © 2001-2020, Tencent Cloud.

声明:蒲公英网站所涉及的原创文章、文字内容、视频图片及首发资料,版权归作者及蒲公英网站所有,转载要在显著位置标明来源“蒲公英”;禁止任何形式的商业用途。违反上述声明的,本站及作者将追究法律责任。
快速回复 返回顶部 返回列表