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双语：新冠病毒疫苗上市及相关工作情况发布会

文章来源：国新办发布时间：2021-05-06 15:54 作者：国新办点击：次

双语：21.1.4新冠病毒疫苗附条件上市及相关工作情况发布会

国新办新闻局局长、新闻发言人胡凯红:

HuKaihong:

女士们、先生们，大家上午好！欢迎出席国务院联防联控机制新闻发布会。今天我们请来了科学技术部副部长徐南平先生，国家卫健委副主任、国务院联防联控机制科研攻关组疫苗研发专班负责人曾益新先生，国家药品监督管理局副局长陈时飞先生，外交部国际司负责人申博先生，工业和信息化部消费品工业司负责人毛俊锋先生，国务院联防联控机制科研攻关组疫苗研发工作组组长郑忠伟先生，国药集团中国生物技术股份有限公司总裁吴永林先生，请他们向大家介绍新冠病毒疫苗附条件上市及相关工作情况，并回答大家关心的问题。首先我们有请徐部长作介绍。

Good morning, ladies and gentlemen. Welcome to this pressconference held by the State Council's inter-agency task force. Today, we arejoined by Mr. Xu Nanping, vice minister of science and technology; Mr. ZengYixin, vice minister of the National Health Commission, and director of thevaccine R&D working group under the State Council's inter-agency taskforce; Mr. Chen Shifei, deputy commissioner of the National Medical ProductsAdministration; Mr. Shen Bo, a person in charge of the Department of InternationalOrganizations and Conferences of the Ministry of Foreign Affairs; Mr. MaoJunfeng, a person in charge of the Consumer Products Industry Department of theMinistry of Industry and Information Technology; Mr. Zheng Zhongwei, a leaderof the vaccine R&D working group under the State Council's inter-agencytask force; and Mr. Wu Yonglin, president of China National Biotec Group (CNBG)affiliated with China National Pharmaceutical Group Co., Ltd. (Sinopharm). Theywill brief you on the conditional marketing approval for the COVID-19 vaccineand other related work in progress, and answer your questions. First, let'sgive the floor to Mr. Xu.

科学技术部副部长徐南平:

XuNanping:

女士们、先生们，大家上午好！12月30日，北京生物制品研究所有限责任公司公布了新冠病毒灭活疫苗III期临床试验期中分析数据结果，其保护效力达到世界卫生组织及国家药监局相关标准要求。这一成果来之不易，是我国广大科技工作者智慧和汗水的结晶，也得益于合作各方的大力支持，在此，向参与疫苗研发工作的机构和全体人员表示热烈祝贺和衷心感谢！

Good morning, ladies and gentlemen. On Dec. 30, the BeijingBiological Products Institute Co., Ltd. announced the interim results of itsphase-3 clinical trials for the COVID-19 inactivated vaccine meeting thestandards of the World Health Organization and our National Medical ProductsAdministration (NMPA). The achievement did not come easily. It embodies thewisdom and hard work of China's scientific community. This has received strongsupport and cooperation from all partners. I hereby would like to express mywarm congratulations and heartfelt appreciation to all the institutes andworkers participating in R&D of the vaccines.

习近平总书记高度重视疫苗研发工作，多次对疫苗研发作出重要指示批示，科研攻关组坚决贯彻落实，按照党中央、国务院的决策部署，始终坚持把疫苗研发摆在重中之重的位置，作为科研攻关的五大主攻方向之一，第一时间启动相关工作；始终坚持以人民为中心，将安全性放在第一位，致力于研发出安全、有效和可及的疫苗；始终坚持遵循科学规律，同步推进灭活疫苗、重组蛋白疫苗、腺病毒载体疫苗、减毒流感病毒载体疫苗和核酸疫苗5条技术路线，最大限度提升疫苗研发的成功率；始终坚持构建人类命运共同体，与阿联酋、巴西等16个国家合作开展国际多中心Ⅲ期临床试验研究，推动我国研究机构和企业与世界各国开展研发生产合作；始终坚持多方联动，产学研结合，组织全国优势力量进行联合攻关，研审联动，在不减少程序、不降低标准，保证安全的前提下，加快疫苗研发进程。到目前为止，我国5条技术路线14个疫苗已经进入临床试验，其中3条技术路线5个疫苗进入III期临床试验。

General Secretary Xi Jinping attaches great importance to vaccineR&D, and has issued important instructions accordingly on a number ofoccasions. These have been implemented resolutely by the vaccine R&Dworking group. In accordance with the decisions and arrangements of the CPCCentral Committee and the State Council, the working group has given toppriority to vaccine R&D, starting work immediately on one of the five majortasks of scientific research. Taking a people-centered approach throughout, theworking group has always put safety first, and is committed to developing safe,effective, and accessible vaccines. Based on science, the working group hasbeen simultaneously working on five technological approaches including inactivatedvaccines, recombinant protein vaccines, adenovirus vector vaccines, vaccinesusing attenuated influenza viruses as vectors, and nucleic acid vaccines, so asto maximize the success rate of vaccine R&D. Always adhering to building acommunity with a shared future for humanity, the working group has cooperatedwith 16 countries such as the United Arab Emirates and Brazil to carry outinternational and multi-centered phase-3 clinical trials for COVID-19 vaccines,promoting R&D cooperation among research institutes and companies both inand outside China. Always adhering to collaboration between different parties,the working group has pooled resources from enterprises, universities, andresearch institutes. Top research groups from around the nation have beengalvanized to work on these tasks. The working group has also coordinated theR&D and examination efforts, and strived to speed up the progress ofvaccine R&D without reducing procedures and lowering standards, whilealways ensuring safety. As of now, 14 kinds of vaccines developed in these fivetechnological approaches have entered clinical trials, among which five kindsof vaccines of three technological approaches have entered phase-3 clinicaltrials.下一步，我们将继续全力以赴，加快疫苗研发，一刻也不放松。一是，要加快推进Ⅲ期临床试验，提供更多不同技术路线的疫苗产品。二是，密切关注全球病毒变异和相关发展情况，科学应对，确保疫苗使用不受影响。三是，持续加大疫苗相关基础研究力度，打造国家战略科技力量，为疫情防控提供坚实的科技支撑。谢谢。

Looking forward, we will continue to do our best to speed upvaccine R&D while sparing no efforts. First, we will facilitate phase-3clinical trials at an accelerated pace, providing more vaccine products ofdifferent technological approaches. Second, we will pay close attention to themutation of the coronavirus and related situation, and respond in a scientificway, making sure the use of vaccines is not affected. Third, we will continueto make greater efforts on the basic R&D front, building China's strategicscientific capacity and providing firm scientific and technological support forepidemic prevention and control. Thank you.

胡凯红:

HuKaihong:

谢谢徐南平副部长。下面有请曾主任作介绍。

Thank you, Mr. Xu. Next, let's give the floor to Mr. Zeng.

国家卫健委副主任、国务院联防联控机制科研攻关组疫苗研发专班负责人曾益新:

ZengYixin:

各位媒体朋友们，新冠肺炎疫情发生以来，在党中央的坚强领导下，在国务院联防联控机制的统一部署下，科研攻关组疫苗研发专班按照五条技术路线，同步开展疫苗的研发和攻关工作，相关疫苗研发企业、科研单位、医疗机构、疾控机构，实验动物的研究机构，以及审评审批机构，遵循人民健康至上的理念，发挥我国制度优势。大家携手共进，共同努力，共同拼搏，创新工作模式，为我国的新冠肺炎疫苗研发作出了重要贡献。

Friends from the media, since the outbreak of the COVID-19pandemic, the vaccine R&D working group has simultaneously worked on fivetechnological approaches under the strong leadership of the CPC CentralCommittee and the unified deployment of the State Council's inter-agency taskforce. Relevant vaccine developing companies, scientific research facilities,medical institutes, epidemic control centers, research centers for animaltesting, and vaccine regulatory agencies have prioritized people's well-beingand leveraged the strength of China's own system. We have made joint effortsand put forward innovative working models, greatly contributing to the COVID-19vaccine R&D.

4月2日，全球第一个新冠疫苗获批开展Ⅰ、Ⅱ期临床试验，到6月23日，全球第一个启动Ⅲ期临床试验，再到6月24日，经过严格的程序，依法依规审批开展紧急使用。再到7月份以来，多个疫苗陆续到境外去开展Ⅲ期临床试验。再到今天第一个疫苗附条件上市，我国的疫苗研发工作始终处于全球第一方阵。在疫苗研发生产过程中，我们始终把疫苗的安全性、有效性放在第一位。

The world's first inactivated vaccine, developed by China, wasapproved for phase-1 and phase-2 clinical trials on April 2. On June 23, Chinawas also the first to carry out phase-3 clinical trials. Then, on June 24,China approved the emergency use of vaccines with strict procedures and inaccordance with laws. Since July, many of China's vaccines have been undergoingphase-3 clinical trials outside China. And today, China has granted conditionalmarketing authorization for our first self-developed COVID-19 vaccine. Chinahas always held a leading position in regard to vaccine R&D in the world.We have also prioritized the safety and efficacy of vaccines during the R&Dprocess.

新冠肺炎疫情是百年不遇的传染病大流行，全球的疫情形势依然严峻。虽然我国一些防控已经取得了战略性成果，但是“外防输入、内防反弹”的压力依然很大，最近境内又陆续发生几起散发性疫情。为了保护高风险人群，今年6月份，按照依法依规批准的《新冠病毒疫苗紧急使用方案》，我们采取小范围起步、稳妥审慎、知情同意自愿的原则，在充分的不良反应监测和应急救治准备的前提下，对高风险人群开展了新冠疫苗的紧急接种。到11月底，累计接种超过了150万剂次，其中约6万人前往境外高风险地区工作，没有出现严重感染的病例报告，疫苗的安全性得到了充分证明，有效性也得到了一定的验证。

As a pandemic unseen in a century, COVID-19 still poses a seriouschallenge to the world. Despite the strategic achievements in controlling thevirus in China, we continue to face enormous pressure in guarding againstimported cases and preventing a resurgence of the outbreak at home. As youknow, we have seen newly reported sporadic cases in China. To protect thehigh-risk population, since June, starting from a small range of people andunder the principle of volunteer participation and informed consent, we haveprudently conducted emergency vaccination, while closely monitoring any adverseeffects and preparing for emergency treatment. By the end of November, we hadadministered more than 1.5 million doses, involving approximately 60,000 recipientswho then travelled abroad to work in high-risk areas. There have been noreports of serious infection among them. This has proven that the vaccine isboth safe and effective.

在此基础上，大家知道，冬春季节是传染病爆发的最常见时期，为了防范冬春季节的疫情爆发，也为了有效保护冷链物流人员、海关边检人员、医疗疾控人员、公共交通人员，以及农贸市场、海鲜市场等一些感染风险相对比较高的人群，我们于12月15日正式启动了我国重点人群的接种工作。半个月来，全国重点人群累计接种已经超过了300万剂次。在接种工作中，我们建立了完善的接种点设置规范、接种人员严格的培训、受种人员的筛查、不良反应的监测、应急救治以及严重不良反应的专家会诊等一系列制度，来确保接种工作安全顺利。这次的300万，加上之前的150万，充分证明了我们的疫苗安全性良好。

As we know, the winter and spring are seasons of frequentinfectious disease transmission. To guard against new COVID-19 outbreaks andprotect the high-risk population, we have started vaccination of key groups ofpeople working in cold-chain logistics, customs, medical services, publictransportation systems, as well as agricultural products and sea food markets.We formally started COVID-19 vaccinations among key groups in China on Dec. 15.In the past 15 days, we have administered over 3 million doses of vaccines.During the vaccination process, we have established mechanisms to buildstandardized vaccination facilities, provide appropriate training for medicalworkers, screen recipients' overall health, closely monitor adverse effects,and provide emergency treatment and medical consultations for recipientssuffering from serious effects. Altogether, the 4.5 million doses of COVID-19vaccines given to recipients have proven that our vaccine is safe.

当然也发生了一定比例的不良反应，总的发生率，跟常规接种的那几种灭活疫苗很接近，主要的表现是一些局部的疼痛、局部的硬结这样一些情况。轻度发热的病例大概不到0.1%，过敏反应等比较严重的不良反应发生率大约为百万分之二。这些情况经过及时处理，都得到了很好的治疗。所以，我们反复强调，疫苗接种时一定要问清楚，有没有严重的过敏反应史，接种的时候一定要有严格的医疗保障措施、医疗单位。另外，还要特别注意接种时的心因性反应和偶合事件，所谓心因性反应，就是心理因素引起的不良反应，比如太紧张了，导致的不良反应。偶合事件是讲在疫苗接种的时候，刚好跟某些疾病或者某些意外因素偶然交织到一起引起的严重事件，这些我们都要高度警惕，应该有专业的人员及时处置。

Of course, we have seen some adverse effects among recipients. Theincidence is similar to other inactivated vaccines, like injection site painand swelling. Less than 0.1% recipients have had mild fever, and about two in amillion showed allergic reactions and other relatively serious adverse effects.Those people have all been taken good care of, with timely treatment. So, it'simportant to ask the recipients if they have any serious allergies beforevaccination and prepare for sufficient medical services in case of any problemsduring the vaccination process. Moreover, we should also prepare forcoincidental events and psychogenic responses, namely adverse effects caused bypsychological factors like nervousness. Coincidental events are adverse effectsthat are correlated with some certain diseases or accidents. Therefore, we needto remain on high alert during the vaccination process and offer timelyprofessional treatment where necessary.

下一步，随着今天批准附条件上市，特别是随着生产供应保障能力的逐步提升，我们将全面有序地推进老年人、有基础疾病的高危人群接种，后续再开展其他普遍人群的接种。目前，我国免疫规划专家咨询委员会已经制定了统一的接种方案，我们将通过有序开展接种，符合条件的群众都能够实现“应接尽接”，逐步在全人群构筑起免疫屏障，来阻断新冠病毒的传播，使新冠肺炎疫情能够得到彻底控制。谢谢。

Inthe next step, as the vaccine has been granted conditional marketingauthorization and as production capacity increases, we will comprehensivelyvaccinate the high-risk population like senior citizens and people withunderlying conditions, and then the general public in an orderly manner. Atpresent, the immunization expert advisory committee has established a unifiedplan that will fully cover the population who need to be vaccinated so as toestablish a strong shield gradually to stop the spread of coronavirus and bringit under total control. Thank you.

胡凯红:

HuKaihong:

下面有请药监局陈时飞副局长作介绍。

Please welcome Chen Shifei, deputy head of the National MedicalProducts Administration (NMPA) for his opening remarks.

国家药品监督管理局副局长陈时飞:

ChenShifei:

各位朋友，大家上午好！我先报告一下大家期待的一个好消息，国家药监局于12月30日，即昨天晚上已经依法附条件批准了国药集团中国生物北京公司新冠病毒灭活疫苗的注册申请，也就是大家通常讲的附条件上市。

Good morning, everyone. I would like to announce some good news:the NMPA has granted conditional marketing authorization for the inactivatedCOVID-19 vaccine developed by the Beijing Biological Products Institute Co.,Ltd. under the China National Biotec Group (CNBG), which is affiliated withSinopharm.

国家药监局深入学习贯彻习近平总书记以人民为中心的思想，在党中央、国务院的坚强领导下，在国务院联防联控机制的协调指挥下，我们在疫情暴发的初期就建立起了疫苗药品研发服务和应急审评审批机制，而且我们强调，要秉承科学精神，尊重科学规律，坚持法规和程序，坚守安全底线，把疫苗药品安全有效的标准作为第一位的遵循。工作中，我们采取主动服务、主动联系研发团队，进行研审联动、滚动审评，把审评、核查、检验实行并联等一系列方法，来提高工作效率，服务和促进安全有效的疫苗药品能够早日上市。

NMPA has been implementing General Secretary Xi Jinping's thoughtof putting people first. Under the strong leadership of the CPC CentralCommittee and the State Council as well as the coordination of the StateCouncil's inter-agency task force, we established a mechanism for research anddevelopment of vaccines and drugs as well as emergency evaluation and approvalsystem in the early stage of the epidemic. We have been taking a science-basedapproach, following legal procedures, and prioritizing the safety and efficacyof the vaccine. We reached out to R&D institutes, adopted a rolling reviewprocedure, and made parallel progress in review, verification and testing toincrease our efficiency in facilitating the marketing of a safe and effectivevaccine.

到目前为止，我们仅在疫苗药品研发方面，跟研发团队、专家团队召开的各种讨论、咨询、研究会议已经超过5500多次。刚刚曾益新主任介绍了，到目前已经批准了14个疫苗进入临床试验，其中5个正在进行Ⅲ期临床试验，包括刚刚宣布的国药中生北京公司的新冠病毒灭活疫苗，还有一批处在临床前阶段的药品正在加速推进。

Up to now, we have conducted over 5,500 discussions, consultationsand research meetings with our R&D teams and expert panels in thedevelopment of vaccines and drugs. As Mr. Zeng has just said, we have authorized14 vaccines to enter clinical trials. Five of them are now in Phase 3 clinicaltrials, including Sinopharm's inactivated vaccine. We are also facilitatingseveral drugs in the pre-clinical trial stage.

众所周知，疫苗是战胜流行病疫情的重要武器，但是其安全性和有效性始终是第一位的。新冠肺炎疫情暴发以后，国家药监局与包括世界卫生组织和其他国家药品监管机构开展了紧密合作，交流疫苗研发信息，协调安全有效的标准。在此基础上，国家药监局药品审评中心专门制定了新冠病毒预防用疫苗研发技术指导原则等五个标准，明确了新冠病毒疫苗上市申请和附条件批准的技术标准，这为我国新冠病毒疫苗的研发和评价提供了依据。

As we all know, vaccines are an important weapon againstepidemics, but their safety and effectiveness are always top priority. Afterthe coronavirus outbreak, the National Medical Products Administration (NMPA)cooperated closely with the World Health Organization (WHO) and the medicalproducts administrators of other countries, and exchanged information onvaccine research and development (R&D) and coordinated the standards ofsafety and effectiveness with them. On this basis, the Center for DrugEvaluation of the NMPA specially formulated five standards including technicalguidelines for R&D of preventive vaccines against COVID-19, and made clearthe technical standards for market access application and conditional marketapproval of vaccines against COVID-19, offering relevant references to the R&Dand evaluation of China's vaccines against COVID-19.

另外，这些标准与世卫组织和其他国家的新冠病毒疫苗的标准要求基本一致，这也为中国疫苗成为世界公共产品提供了科学支持。12月23日，国药中生北京公司在前期滚动提交研究资料的基础上，向国家药监局药品审评中心正式提出附条件上市的注册申请。我们药审中心当即受理。药审中心的专家团队也在前期滚动审评的基础上，对申请人递交的安全性、有效性、质量的可控性等研究资料和数据进行了全面、细致的审核，其中包括药理学、毒理学研究、I期、Ⅱ期临床试验，以及在境外开展的Ⅲ期临床试验，和北京公司的规模化生产工艺和质量控制等药学研究的数据，并对在境内进行的研制活动及境内I、Ⅱ期临床试验现场进行了核查。但是由于疫情的原因，我们无法派专业人员赴境外对Ⅲ期临床试验的质量情况进行现场核查，主要依靠研究单位承担主体责任，保证研究数据的完整、真实、可靠。我们药品的检查部门也开展了探索性远程核查，这个工作在以前还没有开展过，针对疫情无法到达现场，我们采取了远程核查的方法。

In addition, the standards for COVID-19 vaccines are basically thesame as those of the WHO and other countries, providing scientific support forChina's vaccines to become a global public good. The Beijing Institute ofBiological Products of China National Biotech Group on Dec. 23 formallysubmitted a registration application to the Center for Drug Evaluation of theNMPA for conditioned market access of its vaccine based on preliminary rollingsubmissions of research data. The center accepted it immediately. Its expertteam conducted a comprehensive and detailed review of the safety, effectivenessand quality reliability, as well as other submitted research documents and databased on preliminary rolling reviews. The review covered pharmacological andtoxicological research, phase I and II clinical trials, phase III clinicaltrials carried out overseas, and the Beijing Institute's pharmaceuticalresearch data on large-scale production and quality control. The center alsoinspected the sites of domestic R&D activities and phase I and II clinicaltrials; however, we are unable to send experts overseas for on-site inspectionsof phase III clinical trials there due to the pandemic. It is mainly theresearch organizations that assume major responsibility in ensuring theintegrity, authenticity and reliability of the research data. Our druginspection institution also carried out trial remote inspections, a work thatis never before carried out. We undertook remote inspections in response toinaccessible sites existing amid the pandemic.

此外，国家局药品核查中心还依法对北京公司的生产现场开展了注册生产现场核查，北京药监局开展了药品生产质量管理规范检查，中国药品生物制品检定研究院对北京公司试生产的疫苗样品进行了实验室检验和质量标准的复核等，并对申请人递交的根据大规模双盲安慰剂对照的Ⅲ期临床试验期中分析结果得出的疫苗保护力数据，北京中生公司已经公布79.34%，进行了全面分析，并且结合第三方专家组对附条件上市申请的评估意见和建议，以及药审中心专家咨询会议的意见。经过一系列依法依程序的严格审查、审评、核查、检验和数据分析后，综合认为，国药中生北京公司的新冠病毒灭活疫苗已知和潜在的获益，大于已知和潜在的风险，完全达到了预设的附条件上市标准要求。

Besides, the Center for Food and Drug Inspection of NMPA inspectedthe production sites of the Beijing Institute in accordance with the law. TheBeijing Municipal Medical Products Administration reviewed its quality controlpractices in drug production. The National Institutes for Food and Drug Controlconducted laboratory tests on and reexamined the quality of vaccine samplesproduced by the Beijing Institute in trial production. It also thoroughlyreviewed the data of vaccine efficacy (79.34%) submitted and unveiled by theBeijing Institute according to interim results of the phase III clinical trialsbased on large-scale double-blind placebo-controlled analysis. It consulted athird-party expert team for their evaluation and suggestions on conditionalmarket access, and the expert consultation meeting of the Center for DrugEvaluation for further opinions. After a series of rigorous inspections,examinations, evaluations, reviews, and data analysis in accordance with lawsand procedures, we concluded that the known and potential benefits of theinactivated vaccine against COVID-19 of the Beijing Institute of BiologicalProducts of China National Biotech Group were greater than the known andpotential risks, completely meeting preset standards for conditional marketaccess.

鉴于目前新冠肺炎疫情正在全球流行，报告病例已经超过8000万，每天都有大量的住院病人和死亡病人，全世界目前还没有一个治疗新冠病毒疾病的特效药，中国面临“外防输入、内防反弹”的压力，所以我们依照《中华人民共和国疫苗法》《中华人民共和国药品法》等法律法规，对于应对重大突发公共卫生事件急需的疫苗，国家药品监管部门可以附条件批准注册申请。因此，国家药监局依法于12月30日批准了国药中生北京公司新冠病毒灭活疫苗附条件上市。同时，国家药监局将督促国药集团中生北京公司依法依规继续按计划开展Ⅲ期临床试验，要把Ⅲ期临床试验和其他附条件上市后的研究保质保量完成，根据研究的进展和取得的数据结果，以及上市后预防接种中的异常反应等情况，及时更新、补充疫苗的说明书、标签等，并按照规定向药品监管部门申请核准，或者申报备案。

Amid the pandemic, over 80 million cases have been reported aroundthe world, and a large number of patients are being hospitalized and many arepassing away every day. There is no wonder drug against the virus available inthe world yet. China is facing pressure from both potential local transmissionand imported cases, so national medical products administrators can approveregistration applications for conditional market access of the vaccinesurgently needed in response to major public health emergencies in accordancewith the Vaccine Administration Law of the People's Republic of China and thePharmaceutical Administration Law of the People's Republic of China. Therefore,the NMPA approved conditional market access of the Beijing Institute's vaccineon Dec. 30. The NMPA is encouraging the company to continue its phase IIIclinical trials as planned in accordance with laws and regulations, completethem and other post-approval research with quality and quantity guaranteed,update and supplement vaccine instructions and labels in time based on researchprogress, data and results obtained, and absorbing study of abnormal reactionsafter inoculation, and apply to us for approval or filing in accordance withregulations.

下一步，国家药监局将继续坚持科学精神，坚守安全有效的根本标准，争分夺秒地加快后续疫苗药品的应急审评审批和研发服务工作，全力保障经过我们应急批准的疫苗和药品是安全的、有效的，质量是可控的，为最终战胜新冠病毒疫情作出应有的贡献。谢谢。

TheNMPA is engaged in a race against time in emergency evaluation and approval ofvaccines and drugs and in proceeding with their R&D, while adhering toscience-based principles and the premise of safety and effectiveness. We willensure that the vaccines and drugs approved for emergency use by us are safe,effective, and reliable in quality, and make due contributions to the ultimatevictory over the virus. Thank you.

胡凯红:

HuKaihong:

谢谢陈时飞副局长，现在开始提问，提问前请记者通报所代表的新闻机构。

Thank you, Mr. Chen. Now the floor is open to questions. Pleaseidentify your news outlet before raising questions.

中央广播电视总台央视记者:

CCTV:

请问疫苗附条件上市后，监管部门将采取哪些监管措施，确保疫苗的质量和安全？附条件上市在监管方面是不是也要更加严格、更加规范呢？

What regulatory measures will the authorities take to ensure thequality and safety of COVID-19 vaccines conditionally allowed to enter themarket? Should the supervision be stricter and more regulated in terms ofconditional market entry?

陈时飞

ChenShifei:

谢谢您的提问。国家药监局始终坚持药品安全“四个最严”要求，全面落实包括疫苗在内的药品质量安全监管工作，特别是疫苗是用于健康人群的，所以我们高度重视保证疫苗的生产质量安全。新冠病毒疫苗附条件批准上市以后，我们从以下几个方面来加强监管，确保每一支疫苗都是符合质量要求的。

Thank you for your question. The National Medical ProductsAdministration (NMPA) has always adhered to the "four strictestrequirements" in regard to drug safety, and has fully implemented thesupervisory tasks for drug quality and safety, including those of vaccines.Vaccines are intended for healthy people. Therefore, we attach great importanceto ensuring their quality and safety. Following conditional marketingauthorization for COVID-19 vaccines, we have strengthened our supervision inregard to the following aspects to ensure that every vaccine meets qualityrequirements.

首先，质量源于设计。早在疫苗的研发阶段，我们就积极部署、指导国家药监局的直属技术机构和各省级药品监管部门，主动开展跟踪服务，靠前指导，在车间建设阶段就与企业无缝衔接，选派精干的技术人员，对企业进行现场指导。在程序不减少、标准不降低的前提下，及时对符合标准条件要求的疫苗生产企业核发药品生产许可证。通过严格药品生产许可证发放的条件，来保证疫苗生产企业具备技术条件和管理能力。

First, quality comes from adequate arrangement and guidance. Asearly as the research and development stage of vaccines, we actively makearrangements and provide guidelines to the technical institutions directlyunder the NMPA and provincial drug regulatory authorities, in order to trackand guide the relevant work. During the construction of production facilities,we have selected and dispatched competent technicians to provide on-siteguidance to the enterprises involved. On the premise of not reducing proceduresor lowering the standards, we have issued drug production licenses in a timelyway to vaccine manufacturers that meet the required standards. We have ensuredthat vaccine manufacturers have relevant technologies and management capacityby strictly enforcing the issuing rules of drug production licenses.

其次，在生产监管环节，国家药监局按照《疫苗管理法》《药品管理法》和《药品生产质量管理规范》等有关法律法规和规范标准要求，采取了这样几个行动：一是与省级药品监管部门共同强化新冠病毒疫苗质量监管。目前，我们已经多次开展了对国药中生北京公司生产现场的质量安全审计、检查，属地药品监管部门也加大日常监管力度，对国药中生北京公司派出业务能力强的专业人员，常驻企业开展监督活动，保证疫苗生产的过程合规，保证疫苗产品合格。二是组织国家疫苗检查中心对疫苗生产企业开展定期巡查，对疫苗产品开展不定期的抽查。三是组织国家药品评价中心配合卫生健康部门，做好疑似预防接种异常反应监测工作。通过上述举措，监督企业切实履行质量安全主体责任，严格按照核准的生产工艺和质量标准组织生产。对每一批出厂的疫苗，由药品监管部门实行批签发。我们在年初就开始部署扩大批签发能力建设，使批签发能力能够适应疫苗上市以后产量的增加。我们经过严格的考核和综合评估以后，目前已经授予北京市和湖北省药品监管和检验机构承担新冠疫苗的批签发工作。所以，在疫苗附条件上市以后，我们的批签发机构将按照有关法规，以及生物制品批签发管理办法，对每一批疫苗实行严格的资料审核和实验室检验，确保每一支疫苗是合格的。

Second, in the process of production supervision, the NMPA hasacted in accordance with relevant laws, regulations and standards including theVaccine Management Law, the Pharmaceutical Administration Law and the GoodManufacturing Practice (GMP) of Medical Products. We have intensifiedsupervision over the COVID-19 vaccines' quality together with provincial drugregulatory departments. So far, we have carried out many audits and inspectionsof the quality and safety of the production sites of the Beijing BiologicalProducts Institute Co., Ltd. under the China National Biotec Group (CNBG)affiliated with Sinopharm. The drug regulator in the locality where theenterprise is located has stepped up its efforts in regard to dailysupervision, posted capable professionals to the enterprise for oversight, inorder to ensure its compliance in the vaccine production process so that thevaccines are qualified. In addition, we also organized the National Center forVaccine Inspection to conduct regular inspections on vaccine manufacturers andrandom checks on vaccines at irregular intervals. What's more, we arranged forthe Center for Drug Reevaluation to cooperate with health departments to do agood job in monitoring the suspected adverse reactions to the vaccination.Through these measures, we have supervised enterprises so they earnestlyfulfill their primary responsibility for products quality and safety, andorganize production in strict accordance with the approved productiontechniques and quality standards. For each batch of vaccines that leaves thefactory, their lot release will be carried out by the drug regulatoryauthorities. Earlier this year, we began to enhance our lot release capacity toaccommodate the production increase following the vaccines' market entry. Afterstrict examination and comprehensive assessment, we have now authorized drugregulatory and inspection institutions in Beijing and Hubei province toundertake the lot release task of COVID-19 vaccines. Therefore, after thevaccines enter the market conditionally, the lot release agencies will carryout strict data review and laboratory tests on each batch of vaccines followingrelevant regulations and management measures for biological products lotrelease, so as to ensure that each and every vaccine is qualified.

最后，我们也加强了疫苗的全链条监管。国家药监局会同国家卫健委，已经建设了疫苗信息化追溯体系，基本实现了对上市疫苗的全程追溯管理。目前，国内疫苗生产企业和进口疫苗通过自建的追溯系统或者第三方平台实行了全程追溯。谢谢。

Finally, we have improved the whole-chain supervision of vaccines.The NMPA, together with the National Health Commission, has established aninformation technology-based traceability system for vaccines, basicallyrealizing whole-process traceability management of vaccines entering themarket. Currently, domestically produced and imported vaccines are trackedduring the entire process through self-developed traceability systems orthird-party platforms. Thank you.

中央广播电视总台央广记者:

ChinaNational Radio:

我们想了解，与国外的疫苗相比，中国的疫苗在安全性、有效性、可及性方面具备哪些优势？我们应该如何全面评价一个疫苗？谢谢。

We would like to know, compared with foreign vaccines, what arethe advantages of Chinese vaccines in terms of safety, efficacy andaccessibility? How do we evaluate a vaccine comprehensively? Thank you.

国务院联防联控机制科研攻关组疫苗研发工作组组长郑忠伟:

ZhengZhongwei:

感谢这位记者朋友的提问。最近，我看大家对疫苗的安全性、有效性，媒体公布的数据都非常关注。评价一个疫苗有很多的指标，但是我想，非常重要的指标包括安全性、有效性、可及性、可负担性，其中安全性和有效性是最重要的两个评价指标，正如刚才有关嘉宾介绍的一样。疫苗的安全性一般是指在接种疫苗后，受种对象是否会发生不良反应，以及发生不良反应的严重程度。如果受种对象在接种疫苗后不发生不良反应，或者不发生严重不良反应，或者发生严重不良反应的概率很低，那我们就认为疫苗是安全的。大家都知道，疫苗是用于健康人的特殊产品，因此其安全性是第一位的，这也是我们在推进疫苗研发过程当中遵循的根本原则。

Thank you for your question. Recently, I have noted that peopleare very concerned about the safety, efficacy and data published by the mediain regard to the vaccines. There are many indicators for vaccine evaluation,and I think the very important ones include safety, efficacy, accessibility andaffordability, among which safety and efficacy are the most important, asprevious speakers have introduced. The safety of vaccines generally refers towhether there will be any adverse reactions and the severity of these aftervaccination. The vaccines are considered safe if people don't experienceadverse reactions, if they do, they aren't serious, or the probability ofexperiencing serious adverse reactions is quite low. As we all know, vaccinesare special products for healthy people, so their safety is the first priority,which is the fundamental principle we have followed in advancing the researchand development of vaccines.

疫苗的有效性通常是指受种者在接种疫苗后，在接触病原体的时候，是否会被感染，或者感染程度的轻重。如果受种对象在接种疫苗后再次接触病原体不被感染，或者感染的程度比较低，那么我们就认为疫苗是有效的。所以，有细心的同志可能关注到，有的企业在发布有效率数据的时候，还会发布一个对重症的保护率达到什么样的比例，这也就是对疫苗有效率的解释。

Vaccine efficacy refers to whether people will be infected, or thelevel of severity of the infection if they are exposed to the pathogen aftergetting vaccinated. We consider the vaccine to be effective if the personvaccinated remains free from infection, or the infection is relatively mild.Therefore, some may find that when releasing efficacy data, some companies willalso release a protection rate for severely ill patients. This is how weexplain vaccine efficacy.

在疫苗研发过程当中，我们是根据动物实验、I期、Ⅱ期、Ⅲ期临床试验，在动物、在人体、在人体的不同规模先后检测疫苗的安全性，检验疫苗的有效性。我国的新冠疫苗研发，刚才相关嘉宾已经介绍了，在目前进入临床试验的14个疫苗、进入Ⅲ期临床试验的5款疫苗，在动物实验、在I、Ⅱ期临床试验已经充分验证了疫苗的安全性。有一些已经在世界高水平的杂志上发表了结果，也得到了世界卫生组织的高度认同。除了疫苗的安全性、有效性以外，疫苗的可及性、可负担性也是需要我们关注的。因为只有一个疫苗在安全性、有效性有保障的前提下，它的可及性、可负担性均比较好的情况下，这支疫苗才能真正成为公共产品。

In the vaccine development process, we have tested the safety andefficacy of the vaccines on animals and humans on differing scales, based onanimal tests, and phase I, phase II, and phase III clinical trials. As theintroductions of speakers about China's vaccine research and development, atotal of 14 vaccine candidates currently are undergoing clinical trials withfive entering phase III clinical trials. These have been proved to be safe inthe animal tests, and phase I and phase II clinical trials. Some of them havepublished the results in top medical journals around the world, and highlycommended by the WHO. Besides safety and efficacy, accessibility andaffordability of vaccines are also of prime concern. Only if a vaccine is safeand effective, and at the same time accessible and affordable, can the vaccinetruly become a public good.

具体到说哪个疫苗更好，或者说我国疫苗和国外的疫苗哪个更好，我觉得不能简单地进行评价。因为各条路线的疫苗各有优势，这也是我们当初在疫苗研发过程中布局五条技术路线的原因。我们只有综合判定每一个疫苗的安全性、有效性、可及性、可担负性，才能对这个疫苗作出科学评价。像现在正在推进研发的灭活疫苗、重组蛋白疫苗，已经经过了数十年甚至上百年，数十亿甚至上百亿人次的使用，它的安全性、有效性、可及性得到了时间的检验，也得到了科学验证。但是随着人类科技的进步，随着人类社会的发展，随着一系列新技术、新方法应用于疫苗研发，未来一定会有应用新技术、新方法研制出来的疫苗，在安全性、有效性、可及性等方面做得更好。

Talking about which vaccine is better, or comparing Chineseself-developed vaccines and foreign vaccines, I don't think we can draw anysimple conclusions. The reason why we laid out the five technical routes invaccine development is because each of them has its own advantages. Only bycomprehensively reviewing the safety, efficacy, accessibility, andaffordability of each vaccine can we achieve a scientific evaluation. Forexample, inactivated vaccines and recombinant protein vaccines, whose researchand development are currently being advanced, have undergone tests by billionsor even tens of billions of people for many years. Their safety, efficacy, andaccessibility have stood the test of time and been proven through scientificmethods. However, with the development of science and technology and of humansociety, there will be new vaccines developed using new technologies andmethods in the future, which are better in terms of safety, efficacy,accessibility and other aspects.

这次新冠疫情让我们更加充分地认识到，人类就是命运共同体，就是健康共同体。在推进疫苗的研发过程中，我们中国疫苗企业以及研发单位只有一个对手，就是病毒，我们是在和病毒赛跑。在整个研发过程中，我们充分尊重科学规律、科学原则。我国疫苗是最早开展临床试验的，也是最早开展Ⅲ期临床试验的。在推进的过程中，也是严格遵循相关的科学原则，绝不会为了争第一而去抢跑，这就是我们在推进疫苗研发过程当中的基本原则。谢谢大家！

TheCOVID-19 pandemic has made us more aware that humanity is a community with ashared future, and a community of health for all. In the process of advancingvaccine research and development, Chinese vaccine companies and teams have onlyone enemy, which is the virus. We are racing against the advance of the virus.Throughout the research and development process, we fully respect the laws andprinciples of science. China was the first country to launch clinical trialsincluding phase III ones. In the process, we are strictly following relevantscientific principles, and will never compromise these principles in a rush toseek first place. This is our basic principle in the process of advancingvaccine research and development. Thank you all!

美国彭博新闻社记者:

Bloomberg:

我有一些关于疫苗数据的问题，中国生物疫苗有效率方面的数据能不能更多跟我们分享？另外，几支疫苗的有效率数据可能什么时候能公布？如果这些数据公布的时间迟了，会不会导致中国的疫苗落后于西方的疫苗？另外，中国生物怎么能确保产量能同时供应国内和国外的需求？谢谢。

I have some questions about the vaccine data. Can you share withus more information on CNBG's vaccine efficacy data? In addition, when will theefficacy data of other vaccines be released? If the data is released later thanforeign countries, will that mean China's vaccines have fallen behind? Inaddition, how can CNBG ensure that its production can meet both domestic andforeign demand? Thank you.

国药集团中国生物技术股份有限公司总裁吴永林:

WuYonglin:

谢谢您对国药集团中国生物新冠疫苗的关注和关心。国药集团中国生物新冠疫苗在阿联酋和巴林等多个国家进行了大规模的Ⅲ期临床试验，接种人数已经超过了6万人，接种人群样本量涵盖了125个国籍，完成了阶段性保护率数据的评价，目前得到的结果好于临床研究预定的目标，安全性和有效性指标超过了世界卫生组织规定的上市标准，和我们国家批准的附条件上市工作方案的要求，可以在大范围人群中形成有效保护。所以在12月9日、13日，阿联酋和巴林两个国家分别按照世界卫生组织相关的技术标准，审核批准了国药集团中国生物新冠灭活疫苗正式注册上市。昨天我们国家也批准了咱们国家附条件上市的审批。

Thank you for your attention and concern for vaccines of the CNBG,affiliated with Sinopharm. We have conducted large-scale phase III clinicaltrials in the United Arab Emirates, Bahrain, and other countries, involving60,000 volunteers of 125 nationalities. We have completed phased assessment ofthe protection rate and the results have exceeded the clinical research goals.The safety and efficacy exceeded the standards set by the WHO. They meet therequirements of China's conditional approval plan and can help establisheffective immunity in a wide range of public groups. Therefore, on Dec. 9 and13, the UAE and Bahrain respectively reviewed and approved the officialregistration of the CNBG's inactivated vaccine and put it on the market inaccordance with the relevant technical standards of the WHO. Yesterday, Chinaalso granted conditional marketing authorization for the vaccine.

具体的详细数据我们会在晚些时候公布，也会在国内外的科研杂志上发表，敬请大家关注。谢谢。

The detailed data will be announced later, and will also bepublished in Chinese and foreign medical journals. Please pay attention to therelease. Thank you.

CGTN记者:

CGTN:

媒体报道，新冠病毒在不断发生变异，请问病毒变异是否会影响疫苗的保护效果？另外，此次附条件上市的这个新冠疫苗是否能够应对变异后的病毒？谢谢。

Media reports say that the COVID-19 virus is mutating. Will thevirus variants affect the vaccine's effectiveness? Will the vaccine that hasbeen granted conditional marketing approval work against the virus variants?Thank you.

徐南平:

XuNanping:

这位记者提的问题非常重要，因为病毒变异问题一直是全社会关注的一个热点问题，我们科研攻关组对这个问题也高度关注，从一开始我们就成立了专门的课题组，对病毒的变异进行持续研究。比如我们在国家生物信息中心就有一个数据库，这个数据库掌握了全球一百多个国家近30万条新冠病毒基因组序列的数据，这个数据我们每天都分析，现在整体来看，病毒变异每天都在发生，但是都处于正常范围之内。至于这位记者提的病毒变异对疫苗使用效果有什么样的影响，这也是我们高度关注的，特别是近期有媒体报道，在英国发现了一些病毒的变异，对它的传播力产生了显著的影响，这引起了我们高度关注，所以最近我们科研攻关组召开了多次专家研判会议，并且结合我们前期的一些研究结果，对病毒的变异是否影响疫苗使用效果这个问题进行了深入研究。专家研判的结果是，目前没有证据证明我们所观察到的变异会对疫苗的使用效果构成实质性影响。

This is a very important question. The mutation of the COVID-19virus is a problem that many are concerned about. It is also an importantsubject that our research and development team has focused on. We established aspecial research team at the very beginning of our research to study mutationsof the virus. Currently, we have a database of nearly 300,000 COVID-19 genomicsequence data at the China National Center for Bioinformation and we have kepta close eye on the virus' daily variations which are now within a normal rangeon the whole. The effectiveness of the vaccine on the virus variants issomething that we're very concerned about, especially after the media reported thata new COVID-19 variant detected in the U.K. remarkably improved the virus'transmissibility. Given this, together with our previous research, experts fromthe research and development team have further studied the effects that thevirus variants may have on the effectiveness of the vaccines. The resultsshowed that there is currently no evidence to prove that existing geneticmutations in the novel coronavirus will have a substantial effect on theefficacy of COVID-19 vaccines.

但是另外一方面，我们对这个问题也要高度重视，病毒长期传播可能会产生一些变化，对于这个问题，我们科研攻关组采用的思路是“宁可备而不用，不可用而无备”。这种变异现在对疫苗使用没有产生影响，但是未来有可能产生影响，我们就当做它一定会产生影响来进行科技工作部署，这是我们的基本思路，所以我们现在有专门的方案，组织国内优势力量，成立几个课题组，专门对病毒的变异、检测试剂、药物研发、疫苗使用效果等进行专题研究，这些工作都在进行。所以请大家相信科学，相信我们的科学家，我们有信心来应对病毒变异对疫苗使用效果产生的影响，我们一定会为老百姓提供安全、有效、可及的疫苗。谢谢。

However,we must be vigilant about this issue. The long-term spread of the virus maycause some variants to accumulate, so in this regard, our research anddevelopment team has adopted the principle that "it is always better to beprepared than not." The mutations having no effect on vaccines now doesnot rule out the possibility that they may have an effect in the future.Therefore, we have posed this outcome as an absolute certainty and planned ourresearch accordingly. This is the basic principle of our work. We have alreadymade certain plans and several expert groups have been engaging in studies oncertain tasks such as virus variation, detection reagents, drug development,and vaccine effectiveness. Please trust science and the scientists. We have theconfidence to address the effects that virus variants may have on the efficacyof vaccines. We will ensure the supply of safe, effective, and accessiblevaccines to the people. Thank you.

凤凰卫视记者:

Phoenix TV:

请问中国什么时候能够实现全民疫苗化呢？谢谢。

When will the vaccines be available for all Chinese people? Thankyou.

曾益新:

ZengYixin:

传染病的消灭，最终还是得靠疫苗，所以我们也在计划通过新冠疫苗的接种，来建立一个全人群的免疫屏障，最终控制疫情。实际上，我们从今年6月份就开始新冠疫苗的紧急使用，到12月15日，又开展了重点人群的比较大规模的接种，这可以称之为接种工作的第一步，就是对重点人群、感染风险比较高的人群进行接种。第二步，随着疫苗附条件上市的批准，根据疫苗的供应保障能力提升情况，我们将逐步扩大到高危人群，也就是感染新冠病毒以后容易发生重症这类人群的接种，主要包括老年人和有基础疾病的人群。第三步，我们再扩大到全人群的接种。

The eradication of an infectious disease will ultimately depend ona vaccine. We are planning to reach herd immunity through vaccination and havegranted emergency use of COVID-19 vaccines since June. On Dec. 15, we beganvaccinating some priority groups with COVID-19 vaccines. This is the first stepof our vaccination agenda, which aims to ensure that key groups at high risk ofinfection are the first to receive inoculation. Once COVID-19 vaccines areapproved to enter the market and production capacity has increased, we willvaccinate high-risk groups, namely senior adults and people with underlyingconditions, as they are far more likely to suffer severe symptoms afterinfection. After this, we will vaccinate the general public.

关于您刚才问到的免疫屏障的建立，到底需要接种多少人口的比例，可能根据各国人口分布的状态还不完全一样，但是一般认为，大概要做到60%甚至70%的接种率，才能建立对全民的保护。鉴于我国已经批准的这些疫苗安全性良好，有效性也有了很好的证据，所以我们也在此倡导老百姓，在知情同意和排除禁忌症的前提下积极参加疫苗接种，这样做既是保护自己、保护家人、保护他人，也是在为全球的疫情防控作出贡献。谢谢。

Regardingthe issue of how many people should be vaccinated to achieve herd immunity, Ishould point out that the rate could vary depending on the populationdistribution of each country. Generally, the inoculation rate needs to be over60 percent to 70 percent to reach herd immunity. The vaccines that we haveapproved are safe and effective, so I would like to call on the public to getvaccinated on the premise of informed consent and without contraindications. Bydoing so, we are protecting ourselves, our families, and others, as well ascontributing to global pandemic prevention and control. Thank you.

法国新闻社记者:

AFP:

中国新冠病毒疫苗的生产能力现在是多少？谢谢。

What is China's production capacity for COVID-19 vaccines? Thankyou.

工业和信息化部消费品工业司负责人毛俊锋:

MaoJunfeng:

谢谢这位外国记者朋友的提问。中国新冠病毒疫苗的生产能力怎么样，这个问题大家很关心，其实这个问题作为工业主管部门，我们问自己问得更早。所以，工业和信息化部按照习近平总书记关于要推进新冠病毒疫苗研发和产业化链条有机衔接的重要指示精神，一直在密切跟踪疫苗的研发进展，加快推动疫苗产业化进程。为此，我们专门成立了新冠病毒疫苗生产保障工作专班，每周调度重点企业产能建设进度，组织相关省市的工信部门安排专人去对接和服务企业，推动各条技术路线的企业加快产能建设。同时，我们还对新冠病毒疫苗的整个产业链和供应链作了全面梳理，指导企业对关键的原辅料、关键设备以及耗材等重要生产物料的供应风险进行认真的研判和分析，做好上下游供需对接，保障新冠病毒疫苗生产供应链的稳定。

Thank you for your question. This question is of great concern tomany people. In fact, we, as a competent department of the industry, askedourselves this question early on. Hence, the MIIT has closely tracked thedevelopment of COVID-19 vaccines and accelerated the industrialization ofvaccines, following in the spirit of General Secretary Xi Jinping's importantinstructions on advancing the integration of vaccine R&D and theindustrialized chain. To this end, we have set up a special work team to ensurethe smooth production of the COVID-19 vaccine via numerous means. These includescheduling key enterprises’ production capacity building on a weekly basis andorganizing industry and information technology departments in relevantprovinces and cities to assign special personnel to contact and serveenterprises so as to accelerate the production capacity building across varioustechnical routes of vaccine development. Meanwhile, the MIIT has also made acomprehensive review of the entire industry and supply chain of COVID-19vaccines, guiding companies to conduct serious research and analysis on thesupply risks of key raw and auxiliary materials, key equipment, consumables,and other important production materials, and make supply and demand connectionsbetween upstream and downstream enterprises to ensure the stability of theproduction supply chain of COVID-19 vaccines.

根据调度情况，目前国内有18家企业，根据各自的新冠病毒疫苗的研发进展，陆续开展了产能建设。到目前为止，国药中生北京公司、国药中生武汉公司、北京科兴中维三家企业已经完成了今年的产能建设任务，并且他们新冠病毒灭活疫苗的高生物安全等级的生产车间已经通过了多部门联合组织的生物安全验收。特别是国药中生北京公司的灭活疫苗，昨天已经获得了附条件上市批准。所以，中生北京公司也已经启动了大规模生产。

According to the scheduling, a total of 18 domestic enterpriseshave started to build their production capacity in accordance with their vaccineresearch and development progress. So far, three companies, including theBeijing Biological Products Institute and Wuhan Biological Products Instituteof China National Biotech Group, and Sinovac, have fulfilled their productioncapacity building tasks for this year. Their high-biosafety workshops forinactivated COVID-19 vaccines have passed the inspections by multipledepartments. In particular, the inactivated vaccine developed by the BeijingBiological Products Institute of China National Biotech Group was approved forconditional market launch yesterday. The company has now launched large-scaleproduction.

在这些企业开展规模化生产的同时，我们也在组织他们同步并行进行产能扩建工作。所以，这位记者关心的产能，实际上是一个动态持续提升的过程。还有其他技术路线，产能建设也是按照计划在有序推进。所以，随着新冠灭活疫苗产能的进一步提升，以及其他技术路线企业产能路线的逐步完成，我相信，也请大家相信，中国新冠病毒疫苗的生产能力能够满足国内大规模接种需求。

While these enterprises carry out large-scale production, the MIIThas also been organizing them to simultaneously expand their production capacities.Therefore, the production capacity is a dynamic and continuously increasedprocess. For other technical routes, production capacity expansion areprogressing as scheduled. With the further expansion of the production capacityof the inactivated COVID-19 vaccines as well as the gradual production capacityprogress of enterprises engaged in other technical routes, I believe that ourproduction capacity for COVID-19 vaccines is able to meet the demand of massvaccination in China.

下一步，工信部将按照党中央、国务院的决策部署，同各相关部门加强协调配合，形成政策合力，进一步推动产能提升，保障好疫苗生产的供应链畅通，全面做好新冠病毒疫苗规模化生产的组织和保障工作。谢谢。

Next,the MIIT will follow the decisions and plans made by the Central Committee ofthe Communist Party of China (CPC) and the State Council to enhancecoordination and cooperation with relevant departments to form policy synergy,further promote expansion of production capacity, and ensure a smooth supplychain for vaccine production to prepare for an organized and guaranteed massproduction of COVID-19 vaccines. Thank you.

中国日报记者:

ChinaDaily:

美国辉瑞、莫德纳和英国阿斯利康等制药企业都已经宣布了关于疫苗推广计划，请问新冠疫苗附条件上市以后，中国在“新冠肺炎疫苗实施计划”中将发挥怎样的作用？谢谢。

Pharmaceutical companies such as U.S. Pfizer and Moderna as wellas the UK's AstraZeneca have announced plans to promote their vaccines. Whatrole will China play in the COVID-19 Vaccine Global Access Facility (COVAX)after the COVID-19 vaccine is launched in the market conditionally? Thank you.

外交部国际司负责人申博:

ShenBo:

感谢这位记者对疫苗国际合作的关心。疫情无国界，团结抗击疫情、合作促进恢复，是世界各国的共同心愿。中国对疫苗国际合作始终持开放态度，中国政府一直积极支持“新冠肺炎疫苗实施计划”。10月8日，中方同全球疫苗免疫联盟签署了协议，正式加入“实施计划”，这是中国秉持人类卫生健康共同体理念、推动疫苗成为全球公共产品的重要举措。

Thank you for your concern about international cooperation onvaccines. The epidemic knows no borders. It is therefore the common aspirationof all countries in the world to unite against the epidemic and promoterecovery through cooperation. China has always been open to internationalcooperation on vaccines and the Chinese government has actively supportedCOVAX. On Oct. 8, China signed an agreement with Gavi to officially join COVAX,marking an important move of China to uphold the vision of the world as aglobal community of health for all and promote vaccines as a global publicgood.

目前中国已有多支新冠病毒疫苗进入Ⅲ期临床试验，同时还有多支疫苗正在加紧推进I、Ⅱ期临床试验。中国政府一直积极鼓励支持中国疫苗研发企业参与“实施计划”，与有关发起方合作向发展中国家提供疫苗。据了解，不少中国疫苗企业已经向“实施计划”发起方表达了加入的积极意愿，也正在同不同国家商谈疫苗供应计划。我们期待中国疫苗早日入选“实施计划”疫苗库，早日获得世界卫生组织预认证。

At present, many Chinese COVID-19 vaccines have entered phase Ⅲ clinical trials and manyother vaccines are stepping up their phase I and phase II clinical trials. TheChinese government has actively encouraged and supported Chinese vaccineresearch and development enterprises to join COVAX and cooperate with relevantinitiators to provide vaccines to developing countries. It is understood thatmany Chinese vaccine companies have expressed to COVAX their willingness tojoin the program, and are negotiating with different countries regardingvaccine supply plans. We are looking forward to the inclusion of Chinesevaccines in the COVAX vaccine pool and pre-certification of Chinese vaccines bythe World Health Organization at an early date.

中方将继续同各方一道，推动全球疫苗的公平分配，携手助力全球团结抗击疫情，保护世界各国人民的生命安全和身体健康。谢谢。

China will continue to work with all parties to promote theequitable distribution of global vaccines, facilitate global solidarity in thefight against the epidemic, and protect the lives and health of people aroundthe world. Thank you.

环球时报记者:

GlobalTimes:

此次获批附条件上市的新冠疫苗能够提供的抗体持续多长时间，以及有效性能保持多久？谢谢。

Regarding the COVID-19 vaccine that has been granted conditionalmarketing authorization, how long will the antibody and its efficacy last?Thank you.

吴永林:

WuYonglin:

谢谢您的提问。国药集团中国生物在国内进行了Ⅰ、Ⅱ期临床研究，和在国外做的Ⅲ期临床研究，都进行了抗体的持续性观察。根据新冠灭活疫苗Ⅰ、Ⅱ期研究的数据，6个月以上，抗体仍然能够维持在较高水平上。刚才我也讲了，阿联酋、巴林按照世界卫生组织相关技术标准，审核批准了国药集团中国生物新冠疫苗正式注册上市。从临床试验数据结果显示，保护性的数据结果达到了预定目标，符合上市要求。目前，中国、阿联酋、巴林等国家的临床研究还在持续当中，还将继续观察抗体的持久性。按照我们国家附上市工作方案和世界卫生组织相关的技术标准，目前观察到的保护性数据结果达到了预定目标，符合附条件上市的要求。因为新冠疫苗是一种创新性疫苗，其免疫的持久性和保护效果还需要更长时间的持续观察。我们相信，随着Ⅲ期临床的持续推进，我们将会获得并且公布长期的保护性数据。谢谢。

Thank you for your question. CNBG under the State-ownedpharmaceutical giant Sinopharm has conducted clinical research of phase I andII at home and phase Ⅲresearch abroad, with constant observation as to the antibodies. The phase Iand II research data shows that the antibody can maintain at a high level forover six months in humans. Countries such as UAE (United Arab Emirates) andBahrain have approved China's homegrown coronavirus vaccine for their ownpublic use in accordance with WHO standards. And the interim analysis ofclinical trials shows its protective effects have realized and passed therequirements for public use. Countries undertaking clinical researches willfurther observe the durability of the antibody. According to China'srequirements for conditional marketing authorization and WHO technologicalstandards, the interim analysis and data monitoring have achieved their dueobjectives in line with the marketing demand. As an innovative vaccine, itsdurability and protective effect will be verified after a longer period ofobservation. However, we still believe that, with the progress of the phase Ⅲ clinical trial, we willgain and publish data showing long-term protection. Thank you!

新加坡联合早报记者:

LianheZaobao:

刚才提到评估一个疫苗，我们要看它的安全性、有效性、可及性和可负担性，请问这次获批准上市的疫苗价格定位大概在什么样的范围？

As has been mentioned, the assessment of a vaccine involves itssafety, effectiveness, accessibility and affordability. So, what will berelevant price range?

郑忠伟:

ZhengZhongwei:

关于疫苗的价格，我们在定价的时候，一直坚持企业主体。但是在企业定价的时候，有两个原则必须遵循。第一个原则就是公共产品的属性，第二个原则，既然是公共产品，那就只能以成本作为定价的依据。大家知道，一个产品的成本，它的影响因素也是蛮多的，和它的生产规模、使用规模密切相关。我想，随着疫苗附条件上市的获批，我们已经准备好的规模化生产即将展开，我们制定的免疫规划也即将推开。正如刚才曾主任介绍的，我们将开展第一步高风险人群、重点人群，第二步高危人群，第三步全人群的接种。随着工作的推开，成本会得到大幅度下降。无论怎么样，我们坚信，新冠病毒疫苗的价格一定是在老百姓可接受的范围内。谢谢。

The price will be generally decided by the manufacturer. It willfollow two main principles: first, the nature of a public good, second, as apublic good, its price should be based on cost. It is widely known that thecost of a product may vary based on the scale of manufacturing and its usage.We are ready for a large-scale production and the inoculation plan for ourhomegrown vaccine which has been approved for public use. Just as director Zenghas mentioned, we will launch the inoculation plan with a three-step approach:firstly, open to "key groups" or "high-risk groups" andthen inoculation of vulnerable groups before vaccinating the generalpopulation. As the work proceeds smoothly, the cost will be greatly reduced. Webelieve that the price will be affordable and acceptable to the people.

曾益新:

ZengYixin:

我再补充一句，刚才忠伟回答到，疫苗的基本属性还是属于公共产品，价格可能会根据使用规模的大小有所变化。但是一个大前提是，肯定是为全民免费提供，这是一个大前提。谢谢。

The vaccine is a public good in its nature and the price may varydue to its scale of use. But an important premise is that it will be provided freeof charge to all Chinese people. Thank you!

香港经济导报记者:

HongKong Economic Herald:

中国疫苗现在拿到海外的订单情况怎么样？下一步向境外出口方面有哪些优先计划？谢谢。

How many orders has China's vaccine received from overseas? Whatare the preferred exporting plans in the future? Thank you!

申博:

ShenBo:

感谢你的提问。中方始终对疫苗国际合作持开放态度，积极支持本国企业同外国同行开展疫苗研发、生产等合作，共同造福世界人民。刚才有关部门领导和公司代表也介绍了，目前中国有多支疫苗在阿联酋、巴林、阿根廷、秘鲁、巴西、印尼等国开展Ⅲ期临床试验，进展顺利。其中阿联酋、巴林近期相继批准了中国国药集团灭活疫苗的注册使用。

Thank you for your question. China remains open to internationalcooperation and actively supports Chinese enterprises' research and productioncooperation with global counterparts to benefit the whole world. Many Chinesevaccine candidates are undergoing phase Ⅲ trials smoothly in countries such as UAE, Bahrain, Argentina,Peru, Brazil, and Indonesia. Among them, UAE and Bahrain have recently approvedregistration and usage of the inactivated vaccine manufactured by Sinopharm.

中国新冠疫苗研发完成并投入使用后，将坚定履行承诺，将疫苗作为全球公共产品，以公平、合理价格向世界供应。我们也始终高度重视疫苗在发展中国家的可及性和可负担性，将根据具体情况，积极考虑以多种方式向发展中国家提供疫苗，包括捐赠和无偿援助等。我们也呼吁国际社会一道，，共同推动全球疫苗的公平分配，努力让疫苗成为各国人民用得上、用得起的公共产品。谢谢。

After China's vaccine moves to public usage, it will be providedglobally at a fair, reasonable price. We will still attach importance to itsaccessibility and affordability in developing countries and will positivelyoffer them in many ways. Donation and non-reimbursable assistance will also beconsidered in terms of different situations in developing countries. We alsocall on the international community to work together to promote fairdistribution of the vaccine, and strive to make the vaccine a public good thatis accessible and affordable to people worldwide. Thank you!

胡凯红:

HuKaihong:

发布会到此结束，谢谢台上七位发布人，谢谢各位记者朋友。

That's all for today's press conference. Thank you all.

本文来源：国新办

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