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Human genome editing after the “CRISPR babies”: The double-pacing problem and collaborative governance “CRISPR婴儿”之后的人类基因组编辑:双重起搏问题与协同治理
Q1 Social Sciences Pub Date : 2023-03-01 DOI: 10.1016/j.jobb.2022.12.003
Leifan Wang , Lijun Shang , Weiwen Zhang

How to ensure the safe, effective, and ethical use of emerging biotechnologies, such as clustered regularly interspaced short palindromic repeats (CRISPR)-based genome editing, is a global challenge. The occurrence of the “CRISPR babies” in 2018 publicly brought this issue into sharp focus, and led to comprehensive regulatory reforms in China and various countries around the world. The current article analyzes this event-driven regulatory reform in China by elaborating the most salient provisions designed to prevent risk and protect individual rights, public health, and social morality relating to human genome editing in four important sectors of law: biosecurity law, civil code, criminal law and patent law. It highlights that, although regulation is being undertaken, the gaps between the law and advancing technology remain discernible, at both a national and transnational level (i.e., the “double-pacing problem”). Further attention and collaboration will be required to address the ongoing challenges associated with the use of human genome editing.

如何确保安全、有效和合乎伦理地使用新兴生物技术,例如基于簇化规律间隔短回文重复序列(CRISPR)的基因组编辑,是一项全球性挑战。2018年“CRISPR婴儿”的出现,使这一问题成为公众关注的焦点,并引发了中国和世界各国的全面监管改革。本文通过阐述与人类基因组编辑相关的四个重要法律部门(生物安全法、民法典、刑法和专利法)中旨在防范风险、保护个人权利、公共健康和社会道德的最突出条款,分析了中国这一事件驱动的监管改革。报告强调指出,虽然正在进行管制,但在国家和跨国一级,法律和先进技术之间的差距仍然明显(即“双重步调问题”)。需要进一步关注和合作,以应对与使用人类基因组编辑相关的持续挑战。
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引用次数: 1
Study on the COVID-19 epidemic in mainland China between November 2022 and January 2023, with prediction of its tendency 2022年11月至2023年1月中国大陆新冠肺炎疫情研究及趋势预测
Q1 Social Sciences Pub Date : 2023-03-01 DOI: 10.1016/j.jobb.2023.03.001
Yao Bai , Zhihang Peng , Fengying Wei , Zhen Jin , Jinjie Wang , Ximing Xu , Xinyan Zhang , Jun Xu , Zixiong Ren , Bulai Lu , Zhaojun Wang , Jianguo Xu , Senzhong Huang

The prediction system EpiSIX was used to study the COVID-19 epidemic in mainland China between November 2022 and January 2023, based on reported data from December 9, 2022, to January 30, 2023, released by The Chinese Center for Disease Control and Prevention on February 1, 2023. Three kinds of reported data were used for model fitting: the daily numbers of positive nucleic acid tests and deaths, and the daily number of hospital beds taken by COVID-19 patients. It was estimated that the overall infection rate was 87.54% and the overall case fatality rate was 0.078%–0.116% (median 0.100%). Assuming that a new COVID-19 epidemic outbreak would start in March or April of 2023, induced by a slightly more infectious mutant strain, we predicted a possible large rebound between September and October 2023, with a peak demand of between 800,000 and 900,000 inpatient beds. If no such new outbreak was induced by other variants, then the current COVID-19 epidemic course in mainland China would remain under control until the end of 2023. However, it is suggested that the necessary medical resources be prepared to manage possible COVID-19 epidemic emergencies in the near future, especially for the period between September and October 2023.

基于中国疾病预防控制中心2023年2月1日发布的2022年12月9日至2023年1月30日的报告数据,使用EpiSIX预测系统对2022年11月至2023年1月中国大陆地区的新冠肺炎疫情进行研究。模型拟合使用三种报告数据:每日核酸阳性检测数和死亡人数,以及每日COVID-19患者住院床位数。估计总感染率为87.54%,总病死率为0.078% ~ 0.116%,中位数为0.100%。假设新的COVID-19疫情将在2023年3月或4月爆发,由传染性稍强的突变株引起,我们预测2023年9月至10月可能出现大幅反弹,峰值需求在80万至90万张住院床位之间。如果没有其他变异引发新的疫情,那么目前中国大陆的COVID-19疫情进程将保持在可控范围内,直到2023年底。但是,建议准备必要的医疗资源,以应对近期特别是2023年9月至10月期间可能出现的COVID-19疫情突发事件。
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引用次数: 8
Evolutionary analysis of Omicron variant BF.7 and BA.5.2 pandemic in China 中国基因组变异BF.7和BA.5.2大流行的进化分析
Q1 Social Sciences Pub Date : 2023-03-01 DOI: 10.1016/j.jobb.2023.01.002
Yamin Sun , Min Wang , Wenchao Lin , Wei Dong , Jianguo Xu

On December 7, 2022, China adjusted public health control measures, there have been widespread of SARS-CoV-2 infections in Chinese mainland. As the number of infected people increased, the mutation probability of SARS-CoV-2 is also raised. Therefore, it is of great importance to monitor SARS-CoV-2 variants and its mutations in China. In this current study, 665 SARS-CoV-2 genomes from China deposited in the public database were used to analyze the proportion of different variants; to determine the composition of variants in China across different provinces; and analyze specific mutation frequency, focusing on 12 immune escape residues. The results showed that no new mutations were generated on the 12 immune escape residues. The evolutionary analysis of the BF.7 variant circulating in China showed that there is an independent evolutionary branch with unique mutation sites, officially named BF.7.14 by PANGO. This variant may have been imported from Russia to Inner Mongolia at the end of September 2022 and continued its spread in China. The evolutionary analysis of BA.5.2 variant shows that the variant is composed of two sub-variants, named BA.5.2.48 and BA.5.2.49 by PANGO, respectively. This variant may have been imported from abroad to Beijing at the beginning of September 2022 and formed two sub-variants after domestic transmission. Finally, this study showed that current epidemic variants in China were already circulating in other countries, and there were no additional mutations on immune escape residues that could pose a threat to other countries.

2022年12月7日,中国调整了公共卫生控制措施,中国大陆出现了广泛的严重急性呼吸系统综合征冠状病毒2型感染。随着感染人数的增加,严重急性呼吸系统综合征冠状病毒2型的突变概率也随之提高。因此,在中国监测严重急性呼吸系统综合征冠状病毒2型变异及其突变具有重要意义。在目前的这项研究中,使用公共数据库中保存的665个来自中国的严重急性呼吸系统综合征冠状病毒2型基因组来分析不同变体的比例;确定中国不同省份变异株的组成;并分析特异性突变频率,重点分析12个免疫逃逸残基。结果表明,在12个免疫逃逸残基上没有产生新的突变。对中国流传的BF.7变体的进化分析表明,该变体有一个独立的进化分支,具有独特的突变位点,由PANGO正式命名为BF.7.14。该变种可能于2022年9月底从俄罗斯输入内蒙古,并在中国继续传播。BA.5.2变体的进化分析表明,该变体由两个子变体组成,PANGO分别命名为BA.5.2.48和BA.5.2.49。该变体可能于2022年9月初从国外输入北京,并在国内传播后形成两个子变体。最后,这项研究表明,目前在中国流行的变种已经在其他国家传播,免疫逃逸残留物上没有可能对其他国家构成威胁的额外突变。
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引用次数: 11
WITHDRAWN: The WHO and the ICTV rename viruses such as monkeypox. 弃用:世卫组织和国际传播病毒中心对猴痘等病毒重新命名。
Q1 Social Sciences Pub Date : 2022-12-05 DOI: 10.1016/j.jobb.2022.11.003
Jiaxuan Gao

This article has been withdrawn at the request of the author(s) and/or editor. The Publisher apologizes for any inconvenience this may cause. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/our-business/policies/article-withdrawal.

应作者和/或编辑的要求,本文已被撤回。出版商对此造成的不便深表歉意。完整的爱思唯尔文章撤稿政策请访问 https://www.elsevier.com/about/our-business/policies/article-withdrawal。
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引用次数: 0
Vaccination with CanSinoBIO’s inhaled COVID-19 vaccine has begun in China 康西诺生物的吸入式COVID-19疫苗已在中国开始接种
Q1 Social Sciences Pub Date : 2022-12-01 DOI: 10.1016/j.jobb.2022.12.002
Jiaxuan Gao
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引用次数: 1
“Mutation blacklist” and “mutation whitelist” of SARS-CoV-2 SARS-CoV-2“突变黑名单”和“突变白名单”
Q1 Social Sciences Pub Date : 2022-12-01 DOI: 10.1016/j.jobb.2022.06.006
Yamin Sun , Min Wang , Wenchao Lin , Wei Dong , Jianguo Xu

Over the past two years, scientists throughout the world have completed more than 6 million SARS-CoV-2 genome sequences. Today, the number of SARS-CoV-2 genomes exceeds the total number of all other viral genomes. These genomes are a record of the evolution of SARS-CoV-2 in the human host, and provide information on the emergence of mutations. In this study, analysis of these sequenced genomes identified 296,728 de novo mutations (DNMs), and found that six types of base substitutions reached saturation in the sequenced genome population. Based on this analysis, a “mutation blacklist” of SARS-CoV-2 was compiled. The loci on the “mutation blacklist” are highly conserved, and these mutations likely have detrimental effects on virus survival, replication, and transmission. This information is valuable for SARS-CoV-2 research on gene function, vaccine design, and drug development. Through association analysis of DNMs and viral transmission rates, we identified 185 DNMs that positively correlated with the SARS-CoV-2 transmission rate, and these DNMs where classified as the “mutation whitelist” of SARS-CoV-2. The mutations on the “mutation whitelist” are beneficial for SARS-CoV-2 transmission and could therefore be used to evaluate the transmissibility of new variants. The occurrence of mutations and the evolution of viruses are dynamic processes. To more effectively monitor the mutations and variants of SARS-CoV-2, we built a SARS-CoV-2 mutation and variant monitoring and pre-warning system (MVMPS), which can monitor the occurrence and development of mutations and variants of SARS-CoV-2, as well as provide pre-warning for the prevention and control of SARS-CoV-2 (https://www.omicx.cn/). Additionally, this system could be used in real-time to update the “mutation whitelist” and “mutation blacklist” of SARS-CoV-2.

在过去的两年里,世界各地的科学家已经完成了600多万个SARS-CoV-2基因组序列。今天,SARS-CoV-2基因组的数量超过了所有其他病毒基因组的总数。这些基因组记录了SARS-CoV-2在人类宿主中的进化,并提供了有关突变出现的信息。在本研究中,对这些测序基因组的分析鉴定出296,728个de novo mutations (dnm),并发现6种碱基替换在测序基因组群体中达到饱和。在此基础上,编制了SARS-CoV-2的“突变黑名单”。“突变黑名单”上的基因座是高度保守的,这些突变可能对病毒的存活、复制和传播有不利影响。这些信息对SARS-CoV-2基因功能研究、疫苗设计和药物开发具有重要价值。通过dnm与病毒传播率的关联分析,我们确定了185个与SARS-CoV-2传播率正相关的dnm,并将这些dnm归类为SARS-CoV-2的“突变白名单”。“突变白名单”上的突变有利于SARS-CoV-2的传播,因此可用于评估新变体的传播性。病毒突变的发生和进化是一个动态的过程。为了更有效地监测SARS-CoV-2的突变和变异,我们建立了SARS-CoV-2突变和变异监测预警系统(MVMPS),可以监测SARS-CoV-2突变和变异的发生和发展,并为SARS-CoV-2的预防和控制提供预警(https://www.omicx.cn/)。该系统可实时更新SARS-CoV-2的“突变白名单”和“突变黑名单”。
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引用次数: 3
Biosafety and biosecurity in the era of biotechnology: The Middle East region 生物技术时代的生物安全和生物安保:中东地区
Q1 Social Sciences Pub Date : 2022-12-01 DOI: 10.1016/j.jobb.2022.11.002
Laith AL-Eitan, Malek Alnemri

Biotechnology became a paradigm-shifting science among all subfields of biology. The benefits of biotechnology have reached many practical fields, whether human health, animal, and/or agricultural. However, wherever there is a biotechnology practice, there is an associated biohazard with it, and its negative impact may reach all living entities including humans. Therefore, the cooperation of the leading institutions in this field has culminated in creating the concepts and applications of biosafety and biosecurity. The countries of the Middle East are considered biotechnology-practicing and have shown a clear acceptance to this field. But unfortunately, the Middle East region is one that is facing the most multi-challenges, which would constitute real and noticeable concern at the local and international levels. Such challenges represented by wars and armed conflicts, deteriorating economic conditions, the large number of refugees, and the spread of many epidemics. Thus, limiting the region's ability to deal with the surrounding biological hazards and struggling the way to the one health concept. Therefore, this article aims to shed light on the activities of the Middle East countries in the field of biotechnology and to address potential biological threats, whether natural such as the spread of viruses, or intentional such as biological attacks and bioterrorism. The article also shows the capacity of the countries of the region in the field of biosafety and biosecurity based on available information. Accordingly, some countries are lacking the required level of preparedness to face potential biological threats. Multi-institutional and international cooperation between the concerned countries will significantly enhance the capacity of the region in biosafety and biosecurity to meet the level of biological risk.

Search methodology: wide range of related keywords (based on the section) combined with the name of the region, or one country individually have been searched using available search engines and databases such as google scholar and PubMed. After scanning the content of the found results, irrelevant articles have been excluded. Fig. 2, Fig. 3, Fig. 4, Fig. 6, Fig. 7 were created by biorender.com.

生物技术在生物学的所有分支领域中成为一门范式转换的科学。生物技术的好处已触及许多实际领域,无论是人类健康、动物和/或农业。然而,只要有生物技术实践,就会有相关的生物危害,其负面影响可能影响到包括人类在内的所有生物实体。因此,该领域领先机构的合作在创造生物安全和生物安保的概念和应用方面达到了顶峰。中东国家被认为是生物技术的实践者,并对这一领域表现出明确的接受态度。但不幸的是,中东区域正面临最多方面的挑战,这些挑战将在地方和国际一级引起真正和值得注意的关切。这些挑战包括战争和武装冲突、不断恶化的经济状况、大量难民和许多流行病的蔓延。因此,限制了该地区处理周围生物危害的能力,并努力实现一个健康概念。因此,本文旨在阐明中东国家在生物技术领域的活动,并解决潜在的生物威胁,无论是自然的,如病毒的传播,还是故意的,如生物袭击和生物恐怖主义。这篇文章还显示了该地区国家在生物安全和基于现有信息的生物安全领域的能力。因此,一些国家缺乏应对潜在生物威胁所需的准备水平。有关国家之间的多机构和国际合作将大大提高该地区在生物安全和生物安保方面的能力,以应对生物风险水平。搜索方法:使用可用的搜索引擎和数据库(如google scholar和PubMed)搜索广泛的相关关键字(基于部分),并结合该地区或单个国家的名称。扫描发现结果的内容后,已经排除了不相关的文章。图2、图3、图4、图6、图7由biorender.com制作。
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引用次数: 0
Disease X Testing: The results of an international external quality assessment exercise 疾病X检测:国际外部质量评估工作的结果
Q1 Social Sciences Pub Date : 2022-12-01 DOI: 10.1016/j.jobb.2022.11.004
Tian Qin , Han Zheng , Xuelian Luo , Wen Zhang , Jing Yang , Yamin Sun , Na Han , Yuanhai You , Liang Lu , Xin Lu , Di Xiao , Shenshen Jiang , Xuexin Hou , Jinxing Lu , Biao Kan , Jianzhong Zhang , Jianguo Xu

The United Nations Secretary-General Mechanism (UNSGM) for investigation of the alleged use of chemical and biological weapons is the only established international mechanism of this type under the UN. The UNGSM may launch an international investigation, relying on a roster of expert consultants, qualified experts, and analytical laboratories nominated by the member states. Under the framework of the UNSGM, we organized an external quality assurance exercise for nominated laboratories, named the Disease X Test, to improve the ability to discover and identify new pathogens that may cause possible epidemics and to determine their animal origin. The “what-if” scenario was to identify the etiological agent responsible for an outbreak that has tested negative for many known pathogens, including viruses and bacteria. Three microbes were added to the samples, Dabie bandavirus, Mammarenavirus, and Gemella spp., of which the last two have not been taxonomically named or published. The animal samples were from Rattus norvegicus, Marmota himalayana, New Zealand white rabbit, and the tick Haemaphysalis longicornis. Of the 11 international laboratories that participated in this activity, six accurately identified pathogen X as a new Mammarenavirus, and five correctly identified the animal origin as R. norvegicus. These results showed that many laboratories under the UNSGM have the capacity and ability to identify a new virus during a possible international investigation of a suspected biological event. The technical details are discussed in this report.

联合国秘书长调查指称使用生化武器机制是联合国框架下唯一已建立的此类国际机制。UNGSM可根据会员国提名的专家顾问、合格专家和分析实验室的名册开展国际调查。在《联合国可持续发展战略》框架下,我们为指定的实验室组织了一项外部质量保证工作,称为X疾病测试,以提高发现和确定可能引起流行病的新病原体并确定其动物来源的能力。“假设”情景是确定导致许多已知病原体(包括病毒和细菌)检测呈阴性的疫情的病原。在样本中添加了三种微生物,大别班达病毒、乳头状病毒和Gemella spp.,其中后两种尚未被分类命名或发表。动物样本为褐家鼠、喜马拉雅旱獭、新西兰大白兔和长角血蜱。在参与此项活动的11个国际实验室中,有6个实验室准确地将病原体X鉴定为一种新的乳头状病毒,5个实验室正确地将动物来源鉴定为褐家鼠。这些结果表明,在对疑似生物事件进行可能的国际调查期间,联合国生物安全战略框架下的许多实验室都有能力和能力确定一种新病毒。本报告讨论了技术细节。
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引用次数: 0
Assessing decontamination practices at a medical microbiology research laboratory 评估医学微生物研究实验室的去污做法
Q1 Social Sciences Pub Date : 2022-12-01 DOI: 10.1016/j.jobb.2022.08.002
Merna M. Alfy, Sherine B. El Sayed, Mona El-Shokry

To our knowledge, this is the first study to conduct an objective assessment of the routine decontamination practices at a medical microbiology research laboratory (MRL) a year after a biosafety training was provided to all laboratory staff. Between March 28th and June 28th, 2021, unobtrusive observations were carried out to identify-three high-touch surfaces at the MRL during different working hours. Swabbing was used to evaluate the effectiveness of the disinfectant used in the laboratory. All three high-touch surfaces were sampled before and after decontamination with 200 ppm of 5 % sodium hypochlorite (household bleach) to quantify the microbial load and identify the types of organisms residing on the laboratory surfaces. A higher concentration (500 ppm) of 5 % sodium hypochlorite was employed after refresher training was provided to housekeeping staff, and resampling of the three surfaces was carried out during a 4-week follow-up period using the same procedure. The three high-touch surfaces identified were the two sides of the workbench (22 %–24 %) and the front surface of one incubator (14 %). Anthracoid bacilli and Staphylococcus aureus were the most commonly found organisms on laboratory surfaces pre-intervention (100 % and 89 %, respectively) and post-intervention (56 % and 44 %, respectively). Other microorganisms detected included Salmonella spp. (27.7 %), Proteus spp. (5.6 %), Escherichia coli (5.6 %), and Klebsiella spp. (33.3 %). Employing a higher concentration (500 ppm) of sodium hypochlorite significantly (p ≤ 0.000) reduced the total aerobic colony count from an average of 15–250 cfu/cm2 to 10–60 cfu/cm2. This study demonstrated suboptimal decontamination practices at the MRL and the need to apply a higher concentration (500 ppm) of sodium hypochlorite to reduce the overall microbial load. It also demonstrated the importance of quantitative assessment to monitor decontamination practices and ensure staff compliance. More studies are needed to identify bacterial communities within the laboratory, which will help provide guidance regarding the types, proper concentrations, and appropriateness of the in -use disinfectants. Furthermore, large-scale studies on the acceptable level of residual contamination following any decontamination process are urgently recommended.

据我们所知,这是首次对医学微生物学研究实验室(MRL)所有实验室人员进行生物安全培训一年后的常规去污做法进行客观评估的研究。在2021年3月28日至6月28日期间,在不同的工作时间对MRL进行了三个高接触面的非显眼观测。用拭子法评价实验室使用的消毒剂的有效性。在用200 ppm的5%次氯酸钠(家用漂白剂)去污前后,对所有三个高接触表面进行采样,以量化微生物负荷并确定居住在实验室表面的生物类型。在对家政人员进行进修培训后,使用了更高浓度(500 ppm)的5%次氯酸钠,并在4周的随访期间使用相同的程序对三个表面进行了重新采样。确定的三个高接触表面是工作台的两侧(22% - 24%)和一个培养箱的前表面(14%)。类炭疽杆菌和金黄色葡萄球菌是干预前(分别为100%和89%)和干预后(分别为56%和44%)实验室表面最常见的微生物。检出的其他微生物包括沙门氏菌(27.7%)、变形杆菌(5.6%)、大肠杆菌(5.6%)和克雷伯氏菌(33.3%)。使用较高浓度(500 ppm)的次氯酸钠显著(p≤0.000)将总需氧菌落计数从平均15-250 cfu/cm2降低到10-60 cfu/cm2。该研究表明,MRL的去污操作并不理想,需要使用更高浓度(500ppm)的次氯酸钠来减少总体微生物负荷。它还表明了定量评估对监测除污做法和确保工作人员遵守规定的重要性。需要更多的研究来确定实验室内的细菌群落,这将有助于为使用中的消毒剂的类型、适当浓度和适当性提供指导。此外,迫切建议对任何净化过程后残留污染的可接受水平进行大规模研究。
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引用次数: 2
Heat inactivation of monkeypox virus 猴痘病毒的热灭活
Q1 Social Sciences Pub Date : 2022-12-01 DOI: 10.1016/j.jobb.2022.08.001
Christophe Batéjat, Quentin Grassin, Maxence Feher, Damien Hoinard, Jessica Vanhomwegen, Jean-Claude Manuguerra, India Leclercq

Different kinds of media spiked with monkeypox virus (MPXV) were subjected to heat inactivation at different temperatures for various periods of time. The results showed that MPXV was inactivated in less than 5 min at 70 °C and less than 15 min at 60 °C, with no difference between viruses from the West African and Central African clades. The present findings could help laboratory workers to manipulate MPXV in optimal biosafety conditions and improve their protocols.

将不同种类的猴痘病毒(MPXV)加入培养基,在不同的温度和不同的时间进行热灭活。结果表明,MPXV在70°C条件下的灭活时间小于5分钟,在60°C条件下的灭活时间小于15分钟,在西非和中非分支的病毒之间没有差异。本研究结果可以帮助实验室工作人员在最佳生物安全条件下操作MPXV并改进其方案。
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引用次数: 9
期刊
Journal of Biosafety and Biosecurity
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