“黄金品质” 高标准·严要求

<正>云南沃森生物技术股份有限公司创立于2001年,是国内专业从事疫苗、单抗等生物药品研发、生产、销售的现代生物制药企业,为国家认定的高新技术企业和国家企业技术中心。公司于2010年11月在中国深圳证券交易所创业板上市(股票简称:沃森生物;股票代码:300142)。公司已上市的产品包括23价肺炎球菌多糖疫苗、b型流感嗜血杆菌结合疫苗、A群C群脑膜炎球菌多糖结合疫苗和ACYW135群脑膜炎球菌多糖疫苗等。     

接种麻疹疫苗发生过敏反应四例报告

我们在近三年的预防接种工作中,有四名儿童因接种麻疹疫苗发生过敏反应。现报告如下,以引起同道注意。四名儿童均为8～9月龄,已接种过卡介苗、乙肝、百白破、“小儿麻”糖丸等疫苗。否认有其他药物过敏史。在接种麻疹疫苗前均正常,在按量常规接种麻疹疫苗后(疫苗批号分别为武汉生物所89338、兰州生物所91078、92056、92046,有效期内使用)1～15min即     

疫苗分死活

疫苗是利用病毒或细菌等，经过严格的技术工艺制造的生物制品。接种疫苗可使人体产生免疫力，达到预防相应传染病的目的。疫苗按性质分为活疫苗和死疫苗两类。     

从长生生物事件浅谈疫苗的作用与保管

接种疫苗对于人体来说是预防疾病最安全有效的手段,疫苗问题关乎到人的生命健康的问题。本文就长生生物事件谈谈疫苗的作用和保管,本文先描述长生生物事件的背景和经过,让读者先了解长春长生疫苗事件,再谈疫苗对人体的作用和疫苗的作用机制,最后从疫苗的生产、运输和使用过程、国家法律对疫苗的保护三个层面来谈疫苗的保管。     

肺癌免疫逃逸机制与肺癌疫苗

摘要：肺癌是严重威胁人类健康和生命的疾病。肺癌的主要发病机制是癌细胞通过表面抗原的改变、MHC—1分子和共刺激分子表达异常、树突状细胞功能缺陷以及肺癌细胞高表达FasL等机制实现了免疫逃逸。肺癌疫苗是针对肺癌免疫逃逸机制而设计的生物制剂。目前正在研制的肺癌疫苗主要有合成肽疫苗、树突状细胞疫苗、转基因疫苗和核酸疫苗等几类。临床试验表明,这些疫苗能激发针对肺癌特异性抗原的主动免疫反应,但临床效果仍有待进一步的观察。     

美国免疫服务系统

预防接种是预防医学领域最成功的范例.在美国,随着疫苗的广泛使用和种类的不断增加,大多数疫苗可预防传染病正处于或接近历史最低水平.这得益于一个完善的免疫服务体系,包括基础研究、疫苗研发、疫苗生产、市场准入、免疫策略制定、免疫服务和疫苗伤害补偿系统等.但是该系统也面临巨大的挑战:包括疫苗供应、疫苗成本和安全性、成人免疫、疫苗研发和应对生物恐怖的准备.     

生物制品在运输、存储过程中的风险控制分析

正生物制品,是指用微生物或其毒素、酶,人或动物的血清、细胞等制备的供预防、诊断和治疗用的制剂。它包括预防性生物制品、治疗性生物制品和诊断性生物制品。其中疫苗属于预防和控制传染病的预防性生物用品。疫苗不同于一般医用药品,它是通过刺激机体免疫系统,产生免疫物质(如抗体)才发挥其功效,在人体内出现体液免疫、细胞免疫或细胞介导免疫。     

禽流感研究进展与口岸防控对策

本文对禽流感生物特性、流行特征和AIV变异机理、临床症状和病理变化,以及禽流感疫苗研究进展等进行了综述,并针对口岸防控提出对策。     

护卫健康,诚信为先

<正>长期致力于狂犬病的全面防控浙江卫信生物药业有限公司是专业从事疫苗生物制品科研开发、生产及销售的高新技术中美合资企业,连续七年被评为宁波医药工业十强企业。宁波荣安生物药业有限公司是浙江卫信生物药业有限公司投资控股、宁波市科委认定的专业从事疫苗生物制品生产的"高新技术企业"。公司拥有世界一流的先进生产设备和检测仪器和国内资深疫苗生产、研发人才,以严格的GMP     

新型冠状病毒疫苗研发进展与挑战

新型冠状病毒(2019-nCoV)感染暴发流行对全球公众健康构成了严重威胁,疫苗接种是有效预防病毒感染流行的手段。2019-nCoV与急性呼吸综合征冠状病毒(SARS-CoV)和中东呼吸综合征冠状病毒(MERS-CoV)同属于β-冠状病毒。基于对SARS-CoV和MERS-CoV的了解,科学家对2019-nCoV病毒特征的研究、候选抗原及表位的鉴定、动物模型的建立、免疫应答的检测,疫苗的设计等工作取得了快速进展。新型冠状病毒疫苗(新冠疫苗)的研发也取得了快速进展,新冠疫苗类型几乎涵盖了目前疫苗研究的所有形式,包括灭活疫苗、重组蛋白疫苗、病毒载体疫苗、核酸疫苗(mRNA疫苗与DNA疫苗)等。至2020年3月,已有2项新冠疫苗进入了Ⅰ期临床试验,分别为我国军事医学科学院联合天津康希诺生物股份公司研发的基于腺病毒载体的重组新冠疫苗和美国Moderna公司的mRNA 疫苗,两种疫苗均以2019-nCoV的刺突蛋白为抗原靶标。同时,新冠疫苗研发仍面临着许多未知的挑战,如2019-nCoV病毒抗原特征、抗原变异、机体的保护性免疫应答特征以及对老年及基础病人群是否具有保护,新冠疫苗量产的生产工艺等方...     

Preventive vaccines against bioterrorism: evaluation of efficacy and safety

This paper discusses the US Food and Drug Administration's approach to evaluation of vaccines in general, and vaccines against diseases of bioterrorism in particular. We summarize the scientific bases for development and approval of vaccines and then discuss specific issues regarding vaccines against disease organisms that could potentially be used as weapons of bioterrorism.     

Preventive vaccines against bioterrorism: evaluation of efficacy and safety

This paper discusses the US Food and Drug Administration’s approach to evaluation of vaccines in general, and vaccines against diseases of bioterrorism in particular. We summarize the scientific bases for development and approval of vaccines and then discuss specific issues regarding vaccines against disease organisms that could potentially be used as weapons of bioterrorism.     

Recombinant Salmonella vaccines for biodefence

There is a requirement for vaccines to protect against pathogens that may be misused for bioterrorism or biowarfare purposes. In particular, biodefence vaccines are required that may be used for safe and easy immunisation of populations and that can rapidly induce mucosal immunity to provide protection at the lung surface against a range of airborne agents. To address this need, recombinant Salmonella vaccines are being developed. In this review, the technologies used, considerations needed, progress made, and future prospects for developing multivalent Salmonella-based vaccines for biodefence are discussed.     

Encouraging the development of new vaccines

Investment in the development of new vaccines is suboptimal. Changing this situation requires a creative blend of "push" and "pull" strategies. One successful policy model is the Orphan Drug Act, whose key features include large research and development (R and D) tax credits as well as Food and Drug Administration (FDA) counseling and priority review. Such supply-side R and D incentive provisions can be combined with demand-side mandates and vouchers to encourage development of new vaccines. Guaranteed-purchase funds and other pull mechanisms are useful supplementary incentives in the cases of vaccines for bioterrorism and neglected diseases of poverty.     

The strategic plan for preparedness and response to bioterrorism in Korea

Following the Anthrax bioterrorism attacks in the US in 2001, the Korean government established comprehensive countermeasures against bioterrorism. These measures included the government assuming management of all infectious agents that cause diseases, including smallpox, anthrax, plaque, botulism, and the causative agents of viral hemorrhagic fevers (ebola fever, marburg fever, and lassa fever) for national security. In addition, the Korean government is reinforcing the ability to prepare and respond to bioterrorism. Some of the measures being implemented include revising the laws and guidelines that apply to the use of infectious agents, the construction and operation of dual surveillance systems for bioterrorism, stockpiling and managing products necessary to respond to an emergency (smallpox vaccine, antibiotics, etc.) and vigorously training emergency room staff and heath workers to ensure they can respond appropriately. In addition, the government's measures include improved public relations, building and maintaining international cooperation, and developing new vaccines and drugs for treatments of infectious agents used to create bioweapons.     

Prophylaxis and treatment of pregnant women for emerging infections and bioterrorism emergencies

Emerging infectious disease outbreaks and bioterrorism attacks warrant urgent public health and medical responses. Response plans for these events may include use of medications and vaccines for which the effects on pregnant women and fetuses are unknown. Healthcare providers must be able to discuss the benefits and risks of these interventions with their pregnant patients. Recent experiences with outbreaks of severe acute respiratory syndrome, monkeypox, and anthrax, as well as response planning for bioterrorism and pandemic influenza, illustrate the challenges of making recommendations about treatment and prophylaxis for pregnant women. Understanding the physiology of pregnancy, the factors that influence the teratogenic potential of medications and vaccines, and the infection control measures that may stop an outbreak will aid planners in making recommendations for care of pregnant women during large-scale infectious disease emergencies.     

LC16m8: an attenuated smallpox vaccine

The frequency of moderate to severe adverse reactions associated with smallpox vaccines currently stockpiled in the US, and the continued threat of bioterrorism have prompted the development of effective vaccines with improved safety profiles. LC16m8, an attenuated, replicating smallpox vaccine derived from the Lister strain of vaccinia, is currently licensed in Japan where it was safely used in over 50,000 children in the 1970s. It has been shown to have markedly less neurotoxicity than unattenuated vaccines in nonclinical studies. LC16m8 is immunogenic after a single dose, and recent studies in two different animal models have demonstrated protective efficacy equivalent to that of the only FDA-licensed smallpox vaccine. This article reviews the history and available scientific literature regarding LC16m8 and provides comparisons to other smallpox vaccines.     

The current state of H5N1 vaccines and the use of the ferret model for influenza therapeutic and prophylactic development

Highly pathogenic avian influenza H5N1 is a threat to global public health as a natural pandemic causing agent but has recently been considered a bioterrorism concern. The evolving view of the H5N1 virus necessitates the re-evaluation of the current status of H5N1 therapeutics and prophylactics, in particular the preparation of viable H5N1 vaccination strategies as well as the use of ferrets in influenza research. Here the highly pathogenic H5N1 virus dilemma is discussed in context with the current H5N1 vaccine status and the use of the ferret model. Previously, the development of various H5N1 vaccine platforms have been attempted, many of them tested in the ferret model, including vector vaccines, adjuvant vaccines, DNA vaccines, and reverse engineered vaccines. Moreover, as ferrets are a superlative animal model for influenza investigation and vaccine testing, it is imperative that this model is recognized for its uses in prophylactic development and not only as an agent for creating transmissible influenza viruses. Elucidating the ferret immune response and creating ferret immune reagents remain important goals in conjunction with the development and manufacture of H5N1 vaccines. In summary, an efficacious H5N1 vaccine is urgently needed and the ferret model remains an appropriate model for its development.     

Recent changes in the epidemiology of infectious diseases in the Netherlands: the report 'Status of infectious diseases in the Netherlands, 2000-2005'

Based on the changes in the epidemiology of infectious diseases in the Netherlands in 2000-2005, it is possible to formulate a prediction for the immediate future. Developments that one may expect with a reasonable amount of certainty are a further rise in sexually transmitted diseases, continued vulnerability for infectious diseases for which the State Vaccination Programme distributes vaccines, a slow increase in bacterial resistance, an increase in opportunistic infections, and growing risks for the introduction of new micro-organisms via international travel and trade. Much less certain are the developments surrounding avian influenza A/H5N1, ticks and mosquitoes, the rise and spread of new diseases, and bioterrorism.     

Third-generation smallpox vaccine strain-based recombinant vaccines for viral hemorrhagic fevers

Vaccinia virus has been used as a smallpox vaccine. Now that smallpox has been eradicated, the vaccinia virus is expected to be used as a bioterrorism countermeasure and a recombinant vaccine vector for other infectious diseases, such as viral hemorrhagic fevers. Many vaccinia virus strains were used as smallpox vaccines in the smallpox eradication campaign coordinated by the World Health Organization. These strains can be classified into generations, according to the history of improving production methods and efforts to reduce the adverse reactions. Significantly, the third-generation of smallpox vaccine strains, which include modified vaccinia Ankara (MVA) and LC16m8, are currently popular as recombinant vaccine vectors due to their well-balanced safety and immunogenicity profiles. The present review firstly focuses on the characteristics of the smallpox vaccine generations. The historical background of the development of the third-generation smallpox vaccine strains is detailed, along with the history of the transition of the vaccinia virus generation used as vectors for hemorrhagic fever vaccines to the third generation. Among the vaccinia viruses, MVA is currently the most commonly used vector for developing hemorrhagic fever vaccines, including dengue fever, yellow fever, Ebola viral disease, Lassa fever, Rift Valley fever, and Crimean-Congo hemorrhagic fever. LC16m8 is a vaccine candidate for severe fever with thrombocytopenia syndrome. The current status and recent advances in the development of these hemorrhagic fever vaccines using third-generation vaccinia strains are discussed.