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COVID Vaccines (2 types) live tested in Wuhan on multiple patients, Patients want to volunteer for tests

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http://www.xinhuanet.com/politics/2020-04/14/c_1125853128.htm

新冠病毒疫苗研发再加速 两款灭活疫苗启动临床试验
2020-04-14 11:42:10 来源: 新华网


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(聚焦疫情防控·图文互动)(1)新冠疫苗研发再加速 两款灭活疫苗启动临床试验
4月11日,工作人员在国药集团中国生物新冠疫苗生产基地质量检定部门对新型冠状病毒灭活疫苗样品进行杂质检测。新华社记者 张玉薇 摄
新华社北京4月14日电 题:新冠病毒疫苗研发再加速 两款灭活疫苗启动临床试验
新华社记者董瑞丰、张泉
记者14日从国务院联防联控机制科研攻关组获悉,我国两款新冠病毒灭活疫苗获得国家药品监督管理局许可启动一二期合并的临床试验,成为最先获得临床研究批件的采用“灭活”技术路线的新冠病毒疫苗。
此前,军事科学院军事医学研究院腺病毒载体疫苗已获批开展临床试验。
这意味着我国疫苗研发处于何种进度?不同疫苗又各有什么特点?
 效果需继续评估 灭活疫苗工艺更成熟
此次获批进入临床试验的两款新冠病毒灭活疫苗,分别由国药集团中国生物武汉生物制品研究所、北京科兴中维生物技术有限公司各自联合有关科研机构开发。
据了解,两家单位均在1月紧急开展研制工作,于2月底、3月初完成首批疫苗制备并全面进入动物安全性和有效性评价程序。
通常而言,启动一期临床试验之前需完成动物实验,证实可将病毒蛋白送入免疫系统的关键部位,使免疫系统能识别病毒。该过程可通过使用灭活或减活的病毒、重组或提取病毒蛋白等方式实现。
国药集团有关负责人表示,此次获批进入临床试验的灭活疫苗,是通过物理或者化学等方法杀死病毒,但仍保留了病毒引起人体免疫应答活性的一种疫苗。这种技术路线的疫苗有着长期研究基础,具有生产工艺成熟、质量标准可控、保护范围广等特点,在预防甲肝、流感、手足口病、脊髓灰质炎等传染病中均已有广泛应用。
根据国家相关法律法规,相关企业已为紧急使用做好准备。以国药集团中国生物为例,其申报新冠病毒疫苗临床试验批次产量超过5万剂,量产后每批次产量超过300万剂,年产能1亿剂以上,具备大规模灭活疫苗生产能力。
不过,临床试验分为一期、二期、三期,样本量不断扩大,疫苗的安全性和有效性需经过持续验证、依次“过关”。根据世界卫生组织之前发布的消息,这个时间通常需要一年以上。
(聚焦疫情防控·图文互动)(2)新冠疫苗研发再加速 两款灭活疫苗启动临床试验
4月10日,工作人员在国药集团中国生物新冠疫苗生产基地尚未投产的新型冠状病毒灭活疫苗生产车间内测试照度。新华社记者 张玉薇 摄
10亿元资金、“战时节奏” 疫苗研发高速开跑
在应急情况下,疫苗研发进入“战时节奏”。
据了解,国药集团中国生物1月19日即成立了由科技部“863”计划疫苗项目首席科学家杨晓明挂帅的科研攻关领导小组,迅速安排了10亿元研发资金,布局3个研究院所,在两条技术路线上开发新冠病毒疫苗。
其中,灭活疫苗由国药集团中国生物武汉生物制品研究所与中国科学院武汉病毒所在武汉研发、国药集团中国生物北京生物制品研究所与中国疾病预防控制中心病毒病预防控制所在北京研发。基因工程疫苗则由中国生物技术研究院牵头推进。
国药集团有关负责人介绍,科研人员先后完成疫苗株筛选、毒种库建立、抗体制备及鉴定、检测方法建立、生产工艺研究、配伍及配方筛选等一系列新冠病毒疫苗的生产和质控关键技术,迅速开展并完成动物体内有效性及安全性评价等工作。
与此同时,科兴中维的科研团队凭借SARS疫苗研制的相关经验,在浙江省疾控中心、中国医学科学院实验动物研究所、中国疾控中心、中科院生物物理研究所、军事科学院军事医学研究院微生物流行病研究所等单位的合作与大力支持下,新冠病毒疫苗的研发也不断提速。
科兴中维有关负责人表示,公司已将疫苗研制目标调整为应对全球疫情。现有研究数据显示,疫苗对国内外不同新冠病毒毒株均有较好的交叉中和反应,为疫苗在全球范围内的使用提供了数据支持。
疫情紧急,国家药监局也做好应急审评审批的准备,组织专家团队早期介入、同步跟进研发进程,在标准不降低、程序不减少、保证疫苗安全有效的前提下,加快审批流程。
(聚焦疫情防控·图文互动)(4)新冠疫苗研发再加速 两款灭活疫苗启动临床试验
3月16日,科兴中维工作人员展示新型冠状病毒灭活疫苗样品。新华社记者 张玉薇 摄
5条技术路线并举 陆续进入临床试验
疫苗对疫情防控至关重要,对安全性的要求也是第一位的。疫情发生以来,国务院联防联控机制科研攻关组专门设立疫苗研发专班,按照灭活疫苗、重组蛋白疫苗、腺病毒载体疫苗、减毒流感病毒载体活疫苗、核酸疫苗5条技术路线共布局12项研发任务,以确保新冠病毒疫苗研发的总体成功率。
此前,军事科学院军事医学研究院腺病毒载体疫苗已获批开展临床试验。
在3月中旬的国务院联防联控机制新闻发布会上,中国工程院院士王军志曾介绍,我国新冠病毒疫苗研发进展总体上处于国际先进行列,大部分研发团队4月份有望完成临床前研究,并逐步启动临床试验。
王军志表示,在不降低标准、保证安全有效的前提下,我国科学家正争分夺秒加快疫苗研发。
(聚焦疫情防控·图文互动)(3)新冠疫苗研发再加速 两款灭活疫苗启动临床试验
4月10日,工作人员在国药集团中国生物新冠疫苗生产基地尚未投产的新型冠状病毒灭活疫苗生产车间内调试设备。新华社记者 张玉薇 摄
(聚焦疫情防控·图文互动)(5)新冠疫苗研发再加速 两款灭活疫苗启动临床试验
3月16日,工作人员在科兴中维质检实验室进行新型冠状病毒灭活疫苗细菌内毒素检测。新华社记者 张玉薇 摄
(聚焦疫情防控·图文互动)(6)新冠疫苗研发再加速 两款灭活疫苗启动临床试验
3月16日,工作人员在科兴中维质检实验室进行新型冠状病毒灭活疫苗样品抗原含量检测。新华社记者 张玉薇 摄
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【纠错】 责任编辑: 刘阳



New coronavirus vaccine development accelerates, two inactivated vaccines start clinical trials
2020-04-14 11:42:10 Source: Xinhuanet
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(Focus on epidemic prevention and control, graphic interaction) (1) New crown vaccine research and development accelerates two inactivated vaccines to start clinical trials

On April 11, the staff inspected the impurities of the new coronavirus inactivated vaccine samples in the quality inspection department of China National Bio-New Crown Vaccine Production Base of Sinopharm Group. Xinhua News Agency reporter Zhang Yuwei photo

Xinhua News Agency, Beijing, April 14th, Title: Development of new coronavirus vaccine accelerates, two inactivated vaccines start clinical trials

Xinhua News Agency reporters Dong Ruifeng, Zhang Quan

The reporter learned on the 14th from the State Council Joint Prevention and Control Mechanism Scientific Research Group that two of our new inactivated coronavirus vaccines have been approved by the State Drug Administration to initiate a phase I or II clinical trial, becoming the first to adopt clinical research approvals. "The new coronavirus vaccine of the technical route.

Previously, the adenovirus vector vaccine of the Academy of Military Medical Sciences has been approved for clinical trials.

What does this mean for the progress of vaccine development in China? What are the characteristics of different vaccines?

The effect needs to be continuously evaluated. The inactivated vaccine process is more mature

The two new inactivated coronavirus vaccines approved for clinical trials this time were developed by Sinopharm Group Wuhan Biological Products Research Institute and Beijing Kexing Zhongwei Biotechnology Co., Ltd. jointly with relevant scientific research institutions.

It is understood that both units urgently carried out research and development work in January, completed the preparation of the first batch of vaccines at the end of February and early March and entered the animal safety and effectiveness evaluation process in an all-round way.

Generally speaking, animal experiments must be completed before starting the first phase of clinical trials, and it can be confirmed that viral proteins can be sent to key parts of the immune system so that the immune system can recognize the virus. This process can be achieved by using inactivated or inactivated viruses, recombination or extraction of viral proteins.

The relevant person in charge of Sinopharm Group stated that the inactivated vaccine approved for clinical trials this time is a vaccine that kills the virus by physical or chemical methods, but still retains the activity of the virus to cause human immune response. This technical route vaccine has a long-term research foundation, has mature production technology, controllable quality standards, and wide protection. It has been widely used in the prevention of infectious diseases such as hepatitis A, influenza, hand, foot and mouth disease, and poliomyelitis.

According to the relevant national laws and regulations, the relevant enterprises have been prepared for emergency use. Taking Sinopharm Group as an example, its clinical trial batch production of new coronavirus vaccines exceeded 50,000 doses, and after batch production, each batch output exceeded 3 million doses, with an annual production capacity of more than 100 million doses, and has the capacity to produce large-scale inactivated vaccine .

However, the clinical trials are divided into phases I, II, and III, and the sample size is constantly expanding. The safety and effectiveness of the vaccine need to be continuously verified and then "passed" in order. According to previous news released by the World Health Organization, this time usually takes more than a year.

(Focus on epidemic prevention and control, graphic interaction) (2) R & D of new crown vaccine accelerates, two inactivated vaccines start clinical trials

On April 10, the staff tested the illuminance in the new coronavirus inactivated vaccine production workshop that has not yet been put into operation in the Sinopharm New Bio-Crown Vaccine Production Base. Xinhua News Agency reporter Zhang Yuwei photo

One billion yuan of funds, "wartime rhythm"

In an emergency situation, vaccine research and development entered a "wartime rhythm".

It is understood that Sinopharm China Biotechnology established a scientific research leadership team led by Yang Xiaoming, the chief scientist of the vaccine project of the "863" program of the Ministry of Science and Technology, on January 19, and quickly arranged 1 billion yuan in research and development funds and deployed 3 research institutes in Development of new coronavirus vaccines on two technical routes.

Among them, the inactivated vaccine was developed by Sinopharm Group China Bio-Wuhan Biological Products Research Institute and the Chinese Academy of Sciences Wuhan Virus Research Institute, Sinopharm Group China Bio-Beijing Biological Product Research Institute and the Chinese Center for Disease Control and Prevention Beijing Research and Development Institute. The genetic engineering vaccine is led by the Chinese Academy of Biotechnology.

According to the relevant person in charge of Sinopharm Group, scientific researchers have successively completed the production and quality control of a series of new coronavirus vaccines including vaccine strain screening, virus seed bank establishment, antibody preparation and identification, detection method establishment, production process research, compatibility and formulation screening , Quickly develop and complete the effectiveness and safety evaluation of animals.

At the same time, the scientific research team of Kexing Zhongwei relied on the experience of SARS vaccine development in Zhejiang Provincial Center for Disease Control and Prevention, Institute of Laboratory Animals, Chinese Academy of Medical Sciences, Chinese Center for Disease Control and Prevention, Institute of Biophysics, Chinese Academy of Sciences, and Military Medical Research With the cooperation and vigorous support of the Institute of Microbiology and Epidemiology, the research and development of new coronavirus vaccines has also continued to accelerate.

The relevant person in charge of Kexing Zhongwei said that the company has adjusted the vaccine development target to respond to the global epidemic. Existing research data shows that the vaccine has a good cross-neutralization response to different new coronavirus strains at home and abroad, providing data support for the use of vaccines worldwide.

The epidemic situation is urgent, and the State Food and Drug Administration is also preparing for emergency review and approval, organizing an early team of experts to intervene and follow up the research and development process at the same time, speeding up the approval process on the premise that the standards are not lowered, the procedures are not reduced, and the vaccine is safe and effective.

(Focus on epidemic prevention and control, graphic interaction) (4) R & D of new crown vaccine accelerates, two inactivated vaccines start clinical trials

On March 16, the staff of Kexing Zhongwei displayed samples of the new inactivated coronavirus vaccine. Xinhua News Agency reporter Zhang Yuwei photo

5 technical routes simultaneously and successively entered clinical trials

Vaccines are essential for epidemic prevention and control, and safety requirements are also the first. Since the outbreak, the research team of the Joint Defense and Joint Control Mechanism of the State Council has set up a special vaccine research and development team, and laid out a total of 5 technical routes based on inactivated vaccines, recombinant protein vaccines, adenovirus vector vaccines, attenuated influenza virus vector live vaccines, and nucleic acid vaccines Research and development tasks to ensure the overall success rate of new coronavirus vaccine research and development.

Previously, the adenovirus vector vaccine of the Academy of Military Medical Sciences has been approved for clinical trials.

At the press conference of the Joint Defense and Joint Control Mechanism of the State Council in mid-March, Wang Junzhi, an academician of the Chinese Academy of Engineering, once said that the progress of China's new coronavirus vaccine research and development is generally among the best in the world. Most of the research and development teams are expected to complete preclinical research in April and gradually start Clinical Trials.

Wang Junzhi said that without reducing standards and ensuring safety and effectiveness, Chinese scientists are racing to speed up vaccine development.

(Focus on epidemic prevention and control, graphic interaction) (3) R & D of new crown vaccine accelerates, two inactivated vaccines start clinical trials

On April 10, the staff commissioned the equipment in the new coronavirus inactivated vaccine production workshop that has not yet been put into production at the Sinopharm New Bio-Crown Vaccine Production Base. Xinhua News Agency reporter Zhang Yuwei photo

(Focus on epidemic prevention and control, graphic interaction) (5) R & D of new crown vaccine accelerates, two inactivated vaccines start clinical trials

On March 16, the staff conducted a bacterial endotoxin test for the new inactivated coronavirus vaccine in the Kexing Zhongwei Quality Inspection Laboratory. Xinhua News Agency reporter Zhang Yuwei photo

(Focus on epidemic prevention and control, graphic interaction) (6) New crown vaccine research and development accelerates again Two inactivated vaccines start clinical trials

On March 16th, the staff conducted an antigen content test of the new inactivated coronavirus vaccine sample in the Kexing Zhongwei Quality Inspection Laboratory. Xinhua News Agency reporter Zhang Yuwei photo
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[Error correction] Editor in charge: Liu Yang
 
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