全球最大新冠灭活疫苗工厂已就位,独家探访!
已有百年历史的国药集团所属中国生物技术股份有限公司,一直是中国防疫阻击战的国家队、主力军,承担着80%以上的国家免疫规划用疫苗生产任务。
新冠疫情发生后,中国生物迅速启动包括22种呼吸道病原试剂盒应用,以及特异性免疫球蛋白研发等多个科研攻关项目。
面对疫苗研发的重任,中国生物在灭活疫苗和重组蛋白两条技术路线上全力推进。
4月12日,好消息传出:由中国生物武汉生物制品所申报的一类新药——新型冠状病毒灭活疫苗,获得国家药品监督管理局临床试验许可。这是全球首个获得临床试验批件的新冠病毒灭活疫苗。当天,Ⅰ期和Ⅱ期临床试验在河南焦作武陟县顺利启动。
过去两个月,中国生物已建成全球最大的新冠病毒灭活疫苗生产工厂,年产量可达2亿剂。
专家表示,灭活疫苗目前的多种动物实验效果良好。而在参与Ⅰ期和Ⅱ期临床试验的2000名志愿者中,由疫苗接种引起不良反应的发生率和严重程度也远比其他疫苗低得多。
With a history of more than 100 years, China National Biotec Group, a Chinese biopharmaceutical company, supplies more than 80 percent of China's immunization vaccines.
During the COVID-19 pandemic, the company launched several research projects, such as the use of 22 respiratory pathogens test kits and the development of specific immunoglobulin, a type of protein that functions as antibodies.
On April 12, the clinical trial of the inactivated COVID-19 vaccine developed by its subsidiary Wuhan Institute of Biological Products got approved by the National Medical Products Administration, and the vaccine clinical trials started in China's Henan Province the same day.
In the past two months, the company has built with high efficiency the world's largest COVID-19 inactivated vaccine production facility, with construction standards and quality levels meeting international requirements.
Experts say that the vaccine could enter the market by the end of 2020 or early next year. More than 200 million doses of inactivated COVID-19 vaccines can be produced annually.
Experts stress that in terms of effectiveness, the current inactivated vaccine, which was developed with extensive testing on seven types of animals, including monkeys, mice, and rabbits, and combined with other physical and chemical tests, all have proven their effectiveness.
More than 2,000 people have participated in Phase I and II clinical trials, and the data shows that the incidence and degree of adverse reactions are much lower than that of other vaccines.
2020年6月4日晚,国务院总理李克强在由英国主办的全球疫苗峰会视频会议上发表致辞。
李克强指出,在疫情未结束,挑战依旧严峻的形势下,疫苗是抵御病毒侵袭的有力盾牌。中国将继续支持世界卫生组织在统筹疫苗研发等方面发挥核心作用,推进疫苗多中心临床试验和研发成果尽快上市使用,向世界提供安全、有效、高质量的全球公共产品,为实现疫苗在发展中国家可及性和可担负性作出贡献。
总理还表示,中国政府将投入 2000 万美元至全球疫苗免疫联盟(GAVI)。GAVI是一项公私合营的全球卫生合作伙伴关系,旨在增加贫困国家的免疫接种率。
目前,全世界有上百款疫苗正在攻关中,并且研发速度不断打破纪录。在这当中,有10种已经进入临床评价阶段。
At the virtual meeting of Gavi's third Global Vaccine Summit 2020 hosted by the UK on June 4, Chinese Premier Li Keqiang announced that the Chinese government will make a contribution of 20 million U.S. dollars to the funding of Gavi, a UN-backed alliance that helps get vaccines to developing countries, to meet the challenges of COVID-19 between 2021 and 2025.
Li also said that China will continue to support the WHO's central role in coordinating vaccine research and development, and push forward multi-center clinical trials of vaccines.
At the moment, more than 100 candidate vaccines are in development worldwide, 10 of which are already in clinical evaluation. There is an unprecedented race to develop a COVID-19 vaccine worldwide at record speed.
《柳叶刀》发表中国科学家新冠疫苗I期临床试验结果:安全且能诱导免疫反应