中国的国药疫苗在秘鲁出事了?

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moonvalley
楼主 (北美华人网)

一受试者患病 秘鲁暂停中国疫苗临床试验


秘鲁宣布,出于谨慎理由,暂停对中国国药集团(Sinopharm)候选疫苗的临床试验。此前,一受试者确诊发生神经系统问题。      图中,秘鲁一位志愿者正在接种中国国药集团的疫苗 (德国之声中文网)据秘鲁媒体报道,该国卫生当局周五(12月11日)通报说,接种后,一名受试者手臂动弹困难。临床试验项目负责人对新闻界表示,已向医药监管当局上报了这一情况。 这位负责人表示,所发生的可能是"格林-巴利综合症",属于一种无传染性、少见的神经系统疾病,影响四肢活动。 2019年6月,秘鲁就曾发生多起相关病例,之后这个南美国家宣布对5个地区实施紧急状态。 1970年代,在接种猪瘟疫苗时,美国也出现过类似病例。当时,约有450人显示患"格林-巴利综合症"。 DW.COM 中国推进“疫苗外交” 旨在“一举多得” 发达国家正在争相购买国际知名药企的新冠疫苗,而与此同时,中国也在不遗余力地向贫困国家提供中国研发的疫苗。当然,中国的慷慨举动并非没有私心,北京希望以此获得外交层面的回报。 世卫组织反对普遍接种新冠疫苗 阿联酋正式批准使用中国新冠疫苗 根据原定计划,有1.2万人受试的对中国国药集团候选疫苗的临床试验应于本周结束。秘鲁政府曾宣布,若试验成功,将购买2000万剂该疫苗。该数量将可使种该国三分之二人口得到接种。 全球范围,目前已有6万人接种中国国药的这款疫苗,其中包括俄罗斯、沙特和阿根廷的志愿受试者。中国国药集团的疫苗使用非活性病毒,不需像辉瑞/BioNTech和莫德纳(Moderna)疫苗那样需要超低温保存,从而便于运输和储藏。 不过,国药集团迄今未公布有关其所开发疫苗的安全性或有效性的数据。此外,中国疫苗生产商的信誉曾因过期或低质问题受到质疑。 秘鲁属于按人口比例计算死亡率最高的国家。截至周五,该国卫生当局共录得97万9111新冠感染病例、36499人死亡。大流行瘟疫使该国经济受到重创。 https://www.dw.com/zh/%E4%B8%80%E5%8F%97%E8%AF%95%E8%80%85%E6%82%A3%E7%97%85-%E7%A7%98%E9%B2%81%E6%9A%82%E5%81%9C%E4%B8%AD%E5%9B%BD%E7%96%AB%E8%8B%97%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C/a-55915557
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dice
听说澳洲研發的疫苗也出事了 有人打了之后居然得到HIV的抗体 澳洲政府决定放弃买自家的疫苗 转单Novavax跟AZ
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Quiet_Rain
不论哪种疫苗,安全问题现在下结论还早。受试都是万人以上,这么大样本,自然的、随机发生的疾病就可能有很多。
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little_racoon
回复 1楼moonvalley的帖子
格林巴利综合症是疫苗常见的严重副作用,很危险的,如果肌肉瘫痪波及到呼吸肌会致死,比面瘫可是严重多了
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little_racoon
回复 2楼的帖子
还有个法国Sanofi的疫苗研发也出问题了,免疫反应不够,需要推倒重来,他们还拿了美国政府21亿的投资。本来药物开发就是个高风险活动,失败几个很正常。
A
AaronBush
国产和进口疫苗怎么选?张文宏:你说我该怎么答?
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bigjohn123456

Peru Halts Trial for Chinese Covid-19 Vaccine Health Ministry says trial for Sinopharm vaccine was temporarily suspended after a volunteer presented neurological problems Health personnel at Peru’s Cayetano Heredia University in Lima reviewed data in September from a clinical trial of a Covid-19 vaccine being developed by China’s Sinopharm. PHOTO: UPCH/HANDOUT/SHUTTERSTOCK By Ryan Dube Updated Dec. 13, 2020 12:09 am ET
LIMA, Peru—Peru’s Health Ministry said Saturday it has suspended a trial for a Chinese Covid-19 vaccine after a participant presented health problems. The Healthy Ministry said a trial with 12,000 volunteers for China’s Sinopharm vaccine has been temporarily put on hold as it investigates whether the vaccine caused what it described as a “serious adverse event” in one of the participants. The trial was expected to finish in the coming days. Germán Málaga, a health researcher at the Cayetano Heredia University in Lima, where the trial is taking place, said a volunteer presented neurological problems, resulting in difficulty moving his legs. Dr. Málaga told radio station RPP Noticias that he didn’t believe the health problem was due to the vaccine, but more information was needed. “We are concerned about the situation, and we are providing all of our help and support to ensure that it is cleared up,” he said. The United Arab Emirates said this week that its own trial for the Sinopharm vaccine had shown that it was 86% effective in protecting people from Covid-19. The U.A.E.’s trial included 31,000 people, although authorities didn’t disclose how many infection cases the efficacy estimate was based on. The more cases, the more reliable the results are considered to be. The analysis of its effectiveness against Covid-19 was also only for a strain of the vaccine developed in Beijing. Another strain has been developed in Wuhan.
In Peru, it isn’t clear which Sinopharm strain was used in the country’s trial. A spokesman for the Health Ministry didn’t respond to requests for comment. Sinopharm didn’t respond to a request for comment. Chinese vaccine makers face pressure to provide clinical evidence that their experimental candidates work, after leading Western vaccines, including one developed by Pfizer Inc. and German partner BioNTech SE, have been shown to be extremely effective. Public-health experts have criticized China for authorizing emergency use of its vaccines, before solid clinical evidence is presented. Sinopharm is testing its vaccines in Argentina, Bahrain, Egypt, Indonesia, Jordan, Morocco and Russia. Egypt and Indonesia have already received early batches of the vaccines. In China, nearly one million people have received vaccines from Sinopharm, including Chinese workers going abroad, government officials and students. Peru has confirmed more than 36,500 deaths from Covid-19, giving it one of the highest per capita mortality rates in the world. The country of 32 million people has signed a deal with Pfizer to receive some 9.9 million doses of its Covid-19 vaccine. Government officials here hope the first batch of that vaccine will be delivered around March or April. Peru also has signed an agreement to receive vaccines from a World Health Organization-backed initiative, called Covax. That program aims to distribute some 2 billion vaccines to poorer countries by the end of 2021. —Chao Deng contributed to this article. Write to Ryan Dube at [email protected]