人用狂犬疫苗的回顾与展望

早在1885年，路易．巴斯德证明狂犬病毒能通过兔神经系统重复传代而减毒，并制备出有效的疫苗首次用于人体免疫，从而开创了人用狂犬疫苗的发展史。人用狂犬病疫苗的发展经历了从传统的神经组织疫苗到现行的以组织培养疫苗为主的过程，并且正在应用现代生物技术不断改进和发展。     

中国免疫规划用疫苗十年发展状况及趋势分析

免疫规划用疫苗在中国传染病预防控制方面起到举足轻重的作用。我国自2007年实施扩大免疫规划以来, 免疫规划用疫苗共计15种, 可以预防15种疾病。本文从品种、数量、生产企业、质量标准、监管体系5个方面详细分析了近十年中国免疫规划疫苗的发展状况。研究结果显示, 2011—2020年中国免疫规划用疫苗平均剂量约为5.7亿剂次/年;免疫规划用疫苗行业整体发展平稳, 每类疫苗生产企业在1～5家之间且主要依靠国内生产;疫苗质量标准不断提高且与国际标准基本一致;疫苗监管体系不断完善, 覆盖了研发、生产、流通全流程监管。     

宫颈癌疫苗，为何仍未上市

很多健康意识强的内地女性,组团赴港澳“打疫苗”。她们所打的宫颈癌疫苗,8年前已在美国上市,为何迟迟没在内地出现？人种临床试验,或许是原因。     

人用狂犬病疫苗免疫预防研究近况

人用狂犬病疫苗免疫预防研究近况山东省卫生防疫站杨裕华综述山东中医学院王际莘审校狂犬病在世界各大洲均有流行，已成为世界性的灾害。因此，世界各国都非常重视狂犬病的防治研究工作。据新近报道，目前狗狂犬病仍在全世界８７个国家和地区的２４亿人中流行，估计每年因...     

疫苗损耗情况的调查分析

<正> 购置疫苗费用是开展计划免疫工作的一项重要开支,而不必要的疫苗损耗则是对计免资源的浪费。加强疫苗损耗情况的监测,降低疫苗的损耗一直是我们努力的方向。为了解目前市场经济条件下,基层接种的实际损耗情况,南阳市防疫站在1997年开展了五种疫苗损耗情况的调查,现将有关情况报告如下。1 资料与方法     

人用浓缩狂犬疫苗免疫反应

人用浓缩狂犬疫苗免疫反应湖北省荆沙市沙市区卫生防疫站张远萍１９９５年，我们对卫生部武汉生物制品研究所生产的人用浓缩狂犬疫苗进行免疫反应观察，现将结果报告如下。材料与方法一、疫苗人用浓缩狂犬疫苗系卫生部武汉生物制品研究所生产，批号：９４ｉｆ０９（失效：...     

宫颈癌疫苗有望上市

2011年3月9日,在广州市中山大学肿瘤防治中心举办的女性义诊活动上获悉,预防宫颈癌疫苗,国内目前正进行准入临床评估,广州番禺为试验区之一,预计最快2年内可在国内上市。宫颈癌是女性第二大常见恶性肿瘤,我国宫颈癌年调整死亡率为4.3/10万,甘肃和山西部分高发地区可达36.0/10万,全国每年有10万例新发病例,每年有3万例妇女死于此病。除了发病率逐年增加外,由于初次性生活提前(16岁之前)等原因,宫颈癌     

人用狂犬病纯化疫苗免疫效果分析

狂犬病为犬、猫等动物传播的人兽共患病,温血动物为狂犬病的宿主和传染源,人被可疑动物致伤后易感染发病,且病死率几乎达100%.及时进行暴露后的伤口处理和免疫注射是预防狂犬病的根本措施.本试验研究人用纯化疫苗接种后的免疫效果,分析如下.     

Population access to new vaccines in European countries

Time from registration to population access to new vaccines can take considerable time in European countries. Reasons might be found in the regulatory framework, decision-making processes or the assessment of vaccines by evaluating bodies. The aim of this study was to determine whether some decision-making processes can explain between-country differences in the time to population access to new vaccination programs. Information gathered from a survey among European National Vaccine Industry Groups was combined with information from official health authorities, vaccine manufacturers and literature published. Firstly, a retrospective survey was conducted to measure access time to new vaccines against three diseases in 17 European countries. Secondly, qualitative information on the country-specific decision-making frameworks for the introduction of new “vaccination programs” was identified in a cross-sectional survey. Spearman's rank correlation coefficients (ρ) were used for data analysis. The median access time to new vaccines was 6.4 years (95% confidence interval: 5.7–7.1 years) post marketing authorization. National assessments underlying immunization policy decisions (recommendation phase) absorbed most of the access time. Correlation analysis suggested that processes with established timelines and clarity in regard to vaccine evaluation criteria used could ameliorate the effectiveness of the decision-making process. In order to reduce the time to access for new, beneficial vaccines, the underlying vaccination recommendation, implementation and funding process needs to be understood and optimized, where necessary.     

Marketing the COVID-19 vaccine and the implications for public health

COVID-19 vaccines are new brands of consumer health technology being introduced to the market. Considering consumer behaviour approaches in this time of crisis, the risk of vaccine hesitancy, the call for more transparency and effective messaging to gain trust, and equitable distribution of this vaccine, this is unexplored theoretical terrain. This commentary takes a multidisciplinary approach to understand and theoretically explore the marketing, distribution, and acceptance of the COVID-19 vaccine. The paper integrates marketing principles, including advertisement and branding of consumer health technology with supply chain management, public affairs, and public health. A theoretical framework was presented to illustrate this relationship and key areas of concerns. The practical implications relevant to equity, ethics, education, employment, and the economic impact was presented.     

Chikungunya virus vaccines: Current strategies and prospects for developing plant-made vaccines

Chikungunya virus is an emerging pathogen initially found in East Africa and currently spread into the Indian Ocean Islands, many regions of South East Asia, and in the Americas. No licensed vaccines against this eminent pathogen are available and thus intensive research in this field is a priority. This review presents the current scenario on the developments of Chikungunya virus vaccines and identifies the use of genetic engineered plants to develop attractive vaccines. The possible avenues to develop plant-made vaccines with distinct antigenic designs and expression modalities are identified and discussed considering current trends in the field.     

Challenges for the registration of vaccines in emerging countries: Differences in dossier requirements,application and evaluation processes

The divergence of regulatory requirements and processes in developing and emerging countries contributes to hamper vaccines’ registration, and therefore delay access to high-quality, safe and efficacious vaccines for their respective populations. This report focuses on providing insights on the heterogeneity of registration requirements in terms of numbering structure and overall content of dossiers for marketing authorisation applications for vaccines in different areas of the world. While it also illustrates the divergence of regulatory processes in general, as well as the need to avoid redundant reviews, it does not claim to provide a comprehensive view of all processes nor existing facilitating mechanisms, nor is it intended to touch upon the differences in assessments made by different regulatory authorities. This report describes the work analysed by regulatory experts from vaccine manufacturing companies during a meeting held in Geneva in May 2017, in identifying and quantifying differences in the requirements for vaccine registration in three aspects for comparison: the dossier numbering structure and contents, the application forms, and the evaluation procedures, in different countries and regions. The Module 1 of the Common Technical Document (CTD) of 10 countries were compared. Modules 2–5 of the CTDs of two regions and three countries were compared to the CTD of the US FDA. The application forms of eight countries were compared and the registration procedures of 134 importing countries were compared as well. The analysis indicates a high degree of divergence in numbering structure and content requirements. Possible interventions that would lead to significant improvements in registration efficiency include alignment in CTD numbering structure, a standardised model-application form, and better convergence of evaluation procedures.     

Tick-borne encephalitis in China: A review of epidemiology and vaccines

Tick-borne encephalitis (TBE) has been shown to be endemic in northern and western China, including the three mountain areas in Heilongjiang, Jilin, Inner Mongolia, and Xinjiang. In addition, serology evidence shows that there is human infection in south-west provinces of China, including Xizang (Tibet) and Yunnan. TBE in China is caused by the Far Eastern TBE virus subtype and there is no biphasic course for disease presentation. The majority of TBE cases in China have occurred in people who were living or working in forests. TBE vaccines became available in China soon after the virus was identified in the country and they have been used for more than 60 years to date, with different vaccine types used in different periods. Currently, an inactivated and purified whole-virus vaccine produced in a primary hamster kidney (PHK) cell line is used. Clinical trials have shown this vaccine to have higher immunogenicity and fewer adverse reactions than previous TBE vaccines. This paper provides a review on the epidemiology of TBE and the history of TBE vaccination in China.     

药品营销的诚信研究

药品是有目的地调节人的生理机能并规定有适应症或者功能主治、用法和用量的物质,与民众的身体健康和生命安全息息相关.改革开放以来,我国医药企业的营销得到了快速发展.但是在药品营销中却出现了种种不诚信的营销问题,严重侵犯了消费者的正当利益,并对消费者健康构成威胁,不诚信的药品营销导致的严重后果一次次的给我们敲响了警钟.解决药品营销中的诚信缺失问题已成为广大人民群众的迫切要求.文章分析了药品营销中不诚信的表现,指出了其危害性,并提出了解决药品营销中不诚信的途径.     

Acceptability of human papillomavirus vaccines among women older than 26 years

ObjectiveTo examine older women's (>26 years) acceptance of the human papillomavirus (HPV) vaccine, and factors associated with this outcome.Study designA convenience sample of 872 women age 26–77 years were surveyed regarding the likelihood they would accept the HPV vaccine if offered to them by their provider, and factors associated with this outcome. Binomial regression, Chi square and MacNemar's analyses were used to determine associations of this outcome with demographic, attitudinal, and experiential variables.ResultsThe response rate was 60.8%. Half the respondents indicated they would want the vaccine, even if they had to pay for it. In multivariable analyses, the only factor associated with wanting the vaccine was higher self-reported knowledge about HPV (risk ratio 1.43, 95% Confidence Interval 1.12, 1.83). A majority of participants also believed that older women in general would want the vaccine if it were covered by insurance. However, this perspective was significantly diminished if the vaccine had to be paid for out of pocket (97% vs. 22% for 26–45 year olds; 84% vs. 20% for 46–65 year olds, 60% vs. 8% for 66+ year olds, p < 0.001). Nearly all (93%) believed primary care physicians should routinely discuss the vaccine with older women.ConclusionsA high proportion of women over 26 would want the HPV vaccine if offered by their provider, even if they had to pay for it out of pocket. This suggests that if providers were to routinely offer the HPV vaccine to their older patients, many women would choose to get vaccinated.     

MomsTalkShots: An individually tailored educational application for maternal and infant vaccines

IntroductionThe development and initial assessment in a clinical setting of a theory-driven, individually tailored educational application (app), MomsTalkShots, focused on increasing uptake of maternal and infant vaccines is described.MethodsMomsTalkShots algorithmically tailored videos based on parent needs to deliver an intervention that was specifically responsive to individual vaccine attitudes, beliefs and intentions, demographics, and source credibility. MomsTalkShots was evaluated among 1103 pregnant women recruited from 23 geographically and socio-demographically diverse obstetrician-gynecologist offices in Georgia and Colorado in 2017. Self-reported information needs were assessed pre-and post-videos and participants self-reported factors related to usability and analyzed in 2018.ResultsThe vast majority of women reported MomsTalkShots was helpful (95%), trustworthy (94%), interesting (97%) and clear to understand (99%), none of which varied by demographics or parity. Reported usability was slightly lower among vaccine hesitant women, yet the majority reported MomsTalkShots was helpful (91%), trustworthy (85%), interesting (97%) and clear (99%). The majority of women (72%) who did not have enough vaccine information pre-videos reported enough information post-videos.ConclusionsMomsTalkShots was designed to provide individually tailored vaccine information to pregnant women from a population with varied vaccine intentions, confidence and vaccine concerns. MomsTalkShots was extremely well-received among pregnant women, even among women who were initially vaccine hesitant and did not intend to vaccinate themselves and their infants according to the recommended immunization schedule. Next steps include evaluation to assess impact on vaccine uptake and expansion to adolescent and adult vaccines.     

华北地区大学生对HPV及其疫苗的认知现况调查

目的 了解华北地区高校学生对人乳头瘤病毒(humanpapillomavirus,HPV)及其疫苗的认知、态度和疫苗接受意愿,为高校HPV的健康教育和疫苗的推广提供参考.方法 采用自制问卷方便抽样的方法,针对我国华北地区5个市的大学生开展大规模横断面流行病学研究,并分析大学生HPV疫苗接受度的影响因素.结果 2 783...     

The advances in brucellosis vaccines

Brucellosis is a worldwide zoonosis affecting animal and human health. Till now, there is no effective vaccine licensed for brucellosis in humans. Although M5, H38 and 45/20 vaccines were used to prevent animal brucellosis in the early stages, the currently used animal vaccines are S19, Rev.1, S2, RB51 and SR82. However, these vaccines still have several drawbacks such as residual virulence and interfering conventional serological tests. With the development of DNA recombination technologies and the completion of the sequence of Brucella genome, much research focuses on the search for potential safer and more effective vaccines. Preliminary studies have demonstrated that new vaccines, including genetically engineered attenuated vaccines, subunit vaccines and other potential vaccines, have higher levels of protection, but there are still some problems. In this paper, we briefly review the main vaccines that have been used in controlling the brucellosis for decades and the progress in the development of new brucellosis vaccines.