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我公司新冠疫苗在乌兹别克斯坦Ⅲ期临床试验进展顺利

发布者:智飞龙科马      发布时间:2021-02-14 23:20:23      点击率:5043

我公司在乌兹别克斯坦共和国开展的重组新型冠状病毒疫苗(CHO细胞)(简称ZF2001疫苗)国际多中心期临床试验由乌兹别克斯坦共和国创新发展部下属先进技术中心与乌兹别克斯坦共和国国家病毒研究所共同承担。目前进展顺利,并取得了阶段性成果,已有6829人接种了第一针,1634人接种了第二针,截今为止无明显不良反应,疫苗安全可靠。同时ZF2001疫苗的Ⅰ、Ⅱ期临床试验结果也表明该疫苗具有很好的安全性和免疫原性。

目前乌兹别克斯坦共和国内迫切需要新冠肺炎疫苗用于人群接种,形成群体免疫保护,控制疫情的传播蔓延。为此,乌兹别克斯坦共和国正在积极推动我公司ZF2001疫苗的紧急使用许可(EUA)。鉴于我公司在乌兹别克斯坦共和国开展临床试验中所得到的友好合作与支持,双方结下深厚友谊。我公司将优先为乌兹别克斯坦共和国提供紧急使用疫苗,将乌兹别克斯坦共和国作为ZF2001疫苗在该国的共同开发国,未来在该国拥有优先合作生产、联合商业化、新疫苗开发和科学研究的权利。我公司将与乌兹别克斯坦共和国政府共同努力,尽快推动ZF2001疫苗在乌兹别克斯坦共和国获得紧急使用许可(EUA)或上市许可(MA),用于乌兹别克斯坦共和国的新冠肺炎疫情防控,以帮助实现乌兹别克斯坦共和国的公共卫生目标。

    The International Multi-centers Phase III trials of recombinant Novel Coronavirus Vaccine(CHO Cell) (ZF2001 vaccine), sponsored by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd, are undertaken by the Center of Advance Technologies under the Ministry of Innovative Development and the Institute of Microbiology. The trials are actively ongoing in Uzbekistan, and have made initial progress, 6,829 subjects have received the first doses, and 1,634 subjects have received the second doses, so far no significant adverse events have been observed, the vaccine is safe and reliable. At the same time, results from the Phase I and Phase II clinical trials in china has demonstrated the satisfied safety profile and immunogenicity of the vaccine.

    In Uzbekistan, it is now urgently called for large scale vaccinations of COVID-19 vaccines for the people, so as to achieve herd immunity of the population and control the spread of Covid-19. In this case, the Uzbekistan government is actively promoting the emergency usage authorization(EUA) of ZF2001 vaccine. In view of the contribution and efforts of the Ministry of Innovative Development of the Republic of Uzbekistan for ZF2001 vaccine development and the deep friendship both have built since the cooperation of the clinical trials, Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd will give priority to the Republic of Uzbekistan for the emergency usage vaccine supply, and also the Republic of Uzbekistan will act as a co-developing country for ZF2001 in Uzbekistan, with the priority in Uzbekistan on the cooperative production, joint commercialization, new vaccine development and scientific research.

    Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd, together with the government of Uzbekistan, will jointly work on the approval of emergency usage authorization (EUA) and marketing authorization (MA) of ZF2001 vaccine in the Republic of Uzbekistan for the prevention and control of the COVID-19 in the country, so as to achieve the public health goals of Uzbekistan.

(With EUA and MA approval, ZF2001 vaccine will be distributed in the Republic of Uzbekistan under the name ZF-UZ-Vac2001.)