中国人用疫苗上市情况分析与展望

本文分析了中国2019年批签发的人用疫苗种类、数量、生产企业等,对比了国内外疫苗行业发展趋势,展望了中国疫苗发展前景。中国免疫规划疫苗发展平稳,非免疫规划疫苗有较大发展空间,多联多价疫苗、治疗性疫苗和应急疫苗发展迅速。中国需鼓励疫苗产业研发与生产,进一步提高疫苗上市后的安全、有效和合理可及性。     

Vaccine vial monitor availability and use in low- and middle-income countries: A systematic review

IntroductionThe vaccine vial monitor (VVM) registers cumulative heat exposure on vaccines over time. As low- and lower-middle-income countries transition beyond support from the Global Alliance for Vaccines and Immunization (Gavi), they will assume full responsibility for vaccine financing and procurement. It is unclear to what extent countries transitioning out of Gavi support will continue to include VVMs on their vaccines. This paper aims to systematically review evidence on VVM availability and use in low- and middle-income countries to document factors behind global access to and country demand for VVMs. Such results could help identify actions needed to ensure continued use of VVMs in countries that transition out of Gavi support.MethodsWe performed a systematic review of electronic databases, reference lists, and grey literature in English and French languages with publication dates from 2005 onwards. The studies included were analyzed for the following outcomes: (1) availability and deployment of VVM-labeled vaccines; (2) VVM practices and perceptions in the immunization system; (3) vaccine introduction and decision-making processes; (4) Gavi graduation and vaccine program sustainability.ResultsThe study found that VVM availability and use was affected by multiple sourcing of vaccines and the extent to which VVM was included in the vaccine specification in the tendering documents when procuring vaccines. Knowledge about VVM and its impact on the EPI program was found to be high among health workers as well as decision-makers. However, the study also found that weak capacity in key national institutions such as NRA and NPA might impact on demand for VVM. As countries take decisions regarding the adoption of new vaccines, factors such as disease burden and vaccine price may assume greater importance than vaccine characteristics and presentation. Finally, the study found that countries rely largely on the advice and recommendations from technical partners such as WHO and PAHO.ConclusionThe study concludes that global access to and country demand for VVM are dependent on policy statements and recommendations about VVM by key policy institutions such as WHO and UNICEF. The study also concludes that despite Gavi-eligible countries having access to VVM-labeled vaccines, inclusion is often below 100%. Weak institutional capacity in key national agencies such as NRA and NPA seems to be a contributing factor, while other factors include the procurement of clear national policies on the inclusion of VVM on vaccines, along with the capacity to enforce the policy. Finally, the study concludes that knowledge about VVM and its impact on vaccine program efficiency, safety, and cost is critical for transitioning countries’ continuous demand for VVM.     

Confidence in the National Immunization Program among parents in Sweden 2016 – A cross-sectional survey

BackgroundVaccination coverage for infant vaccinations in the Swedish National Immunization Program (NIP) has been high for more than a decade, with approximately 97% of 2-year-old children fully immunized. Vaccination coverage against Human Papilloma Virus (HPV) has been around 80% since introduction for girls in 2012. This indicates high parental confidence in the NIP, but as seen in other European countries rapid shifts in confidence may occur. This study examined vaccine confidence and attitudes towards vaccinations among parents in the Swedish population.MethodsA web-based survey was sent to 1046 parents with children aged 0–15 years, in a panel administrated by The Public Health Agency of Sweden. The survey included questions on vaccination awareness, safety and information channels. The response rate was 87%. Data were weighted to adjust for non-responders and for representativeness of the Swedish population.ResultsParents were categorized as acceptors (79%), questioning acceptors (19%) or selective refusers (2%). When excluding responses for HPV vaccination, the proportion of acceptors increased to 91%. The main reasons for questioning or refusing a vaccine were worry over adverse events, negative or lack of information. Along a spectrum of beliefs, acceptors and questioning acceptors were more similar compared to selective refusers. Nurses at child health clinics constituted the most used vaccination information source for acceptors, whereas selective refusers to a greater extent searched information online and in social media.ConclusionsThe study demonstrates that parents in Sweden have confidence in and are positive towards vaccinations given within the NIP. One in five parents question vaccines, particularly regarding the HPV vaccine, but still concur to the NIP. Information on vaccines online and at vaccination appointments, including vaccine safety, is important for maintaining confidence in vaccination. Conducting recurring studies is valuable for monitoring vaccine confidence and changes in attitudes towards vaccination.     

How influenza vaccination policy may affect vaccine logistics

Background

When policymakers make decision about the target populations and timing of influenza vaccination, they may not consider the impact on the vaccine supply chains, which may in turn affect vaccine availability.

Purpose

Our goal is to explore the effects on the Thailand vaccine supply chain of introducing influenza vaccines and varying the target populations and immunization time-frames.

Methods

We Utilized our custom-designed software HERMES (Highly Extensible Resource for Modeling Supply Chains), we developed a detailed, computational discrete-event simulation model of the Thailand's National Immunization Program (NIP) supply chain in Trang Province, Thailand. A suite of experiments simulated introducing influenza vaccines for different target populations and over different time-frames prior to and during the annual influenza season.

Results

Introducing influenza vaccines creates bottlenecks that reduce the availability of both influenza vaccines as well as the other NIP vaccines, with provincial to district transport capacity being the primary constraint. Even covering only 25% of the Advisory Committee on Immunization Practice-recommended population while administering the vaccine over six months hinders overall vaccine availability so that only 62% of arriving patients can receive vaccines. Increasing the target population from 25% to 100% progressively worsens these bottlenecks, while increasing influenza vaccination time-frame from 1 to 6 months decreases these bottlenecks.

Conclusion

Since the choice of target populations for influenza vaccination and the time-frame to deliver this vaccine can substantially affect the flow of all vaccines, policy-makers may want to consider supply chain effects when choosing target populations for a vaccine.     

Two media-reported vaccine events in China from 2013 to 2016: Impact on confidence and vaccine utilization

BackgroundChina media reported infant deaths following hepatitis B vaccination in late 2013, leading to temporary suspension of hepatitis B vaccine (HepB Event) until the deaths were shown to be coincidental and the vaccine was of standard, good quality. In 2016, a criminal ring in Shandong province that had been purchasing, improperly storing, and reselling Category 2 vaccines (private-sector) to 60 (of 200,000) clinics for 5 years, was exposed, publicized, and prosecuted, and the potential health and epidemiological impacts were investigated to determine whether revaccination was necessary (Shandong Vaccine Event).MethodsWe assessed parental confidence in vaccines through 9 telephone surveys in 6 and 11 provinces before, during, and after the two events. Provider confidence was assessed through in-person interviews following each event. Vaccine utilization was assessed using Immunization Information Management System data from township clinics.ResultsIn the early stages of each event, approximately 30% of parents indicated vaccine hesitancy and 18% said they would refuse routine immunization. Five and nine months after each event, hesitancy and refusal decreased, but not to pre-event levels. During the Shandong Vaccine Event, 49·1% of parents indicated refusal to use Category 2 vaccines; six months later, the rate was 32·8%. Use of HepB decreased by 21% during the first 2 weeks of the HepB Event and by 12·6% during the first 4 weeks of Shandong Vaccine Event, but returned to baseline in less than 3 months. Use of Category 2 vaccine decreased by 49·5% in the first 3 weeks of the Shandong Vaccine Event and by 28·7% 6 months later. After the Shandong Vaccine Event, 64% of clinicians held high confidence in routine immunization, lower than at baseline.ConclusionsThe two events caused mistrust, loss of confidence, and decreases in use of vaccines by parents and providers. In addition to ensuring immunization program integrity, effective communications and ongoing monitoring of vaccine use and confidence should be included to restore confidence and trust in vaccines.     

Evaluation of the 2018–2019 vaccine effectiveness against medically attended influenza-like illness using medical records and claims data

BackgroundHealthcare administrative databases are a rich source of information that could be leveraged to estimate real-world influenza vaccine effectiveness (VE). We aimed to evaluate the VE of standard egg-based influenza vaccines and determine if administrative healthcare data provide accurate VE estimates compared to the US CDC data.MethodsThis retrospective cohort study was conducted during the 2018–2019 influenza season. Individuals who had at least one relevant record per year between 2015 and 2019 in their electronic medical record were included. Individuals were considered protected 14 days after receiving an influenza vaccine. The outcome was the occurrence of medically attended influenza-like illness (MA-ILI) defined by clinical diagnostic codes. Adjusted odds ratios (aORs) were derived from multivariate logistic regression and adjusted VE (aVEs) were calculated using 100 × (1-aORs).ResultsA total of 5,066,980 individuals were included in the analysis with 1,307,702 (25.8%) considered vaccinated. Overall, the median age was 54 (IQR, 32–66) and 58.1% were female. Vaccine protection against MA-ILI was moderate in children and low in adults. All estimates were lower than VEs reported by the CDC for the 2018–2019 influenza season. Our results were robust to potential loss to follow up, but misclassification bias and residual confounding led to underestimation of the 2018–2019 aVE. When stratified by the number of primary care visits, aVE estimates and vaccination coverage increased with the number of primary care visits, reaching estimates similar to those obtained by the US CDC and US national vaccination coverage among those with ≥ 6 primary care visits, resulting in significant positive vaccine protection in frequent healthcare users.ConclusionsModerate and low aVEs were observed during the 2018–2019 season using administrative healthcare data, which was likely due to detection and misclassification biases, correlated with healthcare seeking behaviour, leading to an underestimation of the 2018–2019 influenza VE.     

中国2012年国家免疫规划疫苗常规免疫报告接种率分析

目的分析2012年中国（未包括香港、澳门特别行政区和台湾地区,下同）国家免疫规划（NationalImmunizationProgram,NIP）疫苗常规免疫接种率监测报告,提出改进建议。方法通过描述性分析结合比值（Ratio,R值）评价,对2012年全国省（自治区、直辖市,下同）、县（区、市、旗、兵团师,下同）、乡（镇、街道、社区、兵团团场,下同）NIP疫苗常规免疫接种率监测报告接种率、报告数据质量进行分析评价。结果2012年全国常规免疫接种率监测报告县、乡报告率分别为97．87％和97．57％。2012年全国报告接种NIP疫苗共计387683777剂,全国22剂NIP疫苗报告接种率均≥99％,乙型肝炎疫苗首剂（TheFirstDoseofHepatitisBVaccine,HepB．）及时报告接种率95．74％。全国90．4％的县、79-3％的乡所有剂次NIP疫苗报告接种率〉90％,HepB．及时接种率≥90％的县、乡分别占87．0％、73．2％。报告接种率〈90％的县、乡主要分布于西藏、青海、内蒙古、新疆等西部地区。全国NIP疫苗以县为单位各剂平均报告接种率,除HepB．及时接种率、A＋C群脑膜炎球菌多糖疫苗第2剂、白喉．破伤风联合疫苗外,其余均≥98％。全国NIP疫苗22剂报告接种率以乡为单位总和平均为96．59％。中部地区最高（98．40％）,西部地区最低（94．26％）。全国33．8％的县白喉．破伤风一百日咳联合疫苗（Diphtheria．TetanusandPertussisCombinedVaccine;DTP）的脱漏率〉5％,8．99％的县DTP脱漏率≥10％,主要分布在中、西部地区。尺值评价结果显示,对应儿童不同年龄段疫苗剂次,可信度有所变化,其中36-48月龄段数据似可信度最高,其次为12月龄和18～24月龄段,儿童6岁段报告数据似可信度最低。结论全国NIP疫苗常规免疫接种率监测报告完整性和报告接种率均处于较高水平。全国省、县、乡报告接种率水平总体趋于一致,且处于较高水平,但地域差异依然存在,报告接种率较低的县、乡主要分布在西部地区。当前监测数据报告质量有待改善,直接识别低接种率地区能力较弱,需结合各地疾病监测、疫苗使用情况和接种率调查结果,综合评价各地接种率水平。     

Changes and remaining challenges for the Japanese immunization program: Closing the vaccine gap

The Japanese immunization program has made considerable progress since 2009: several new vaccines have been introduced and most are included in the National Immunization Program (NIP). In October 2020, the Japanese law on immunization was revised, which resulted in a few laudable achievements. First, rotavirus vaccines were added to the NIP, 10 years after their introduction, and noteworthy studies of vaccine effectiveness and the incidence of intussusception in Japanese children were published. Second, rules on vaccine intervals—which had been a longstanding concern—were withdrawn. In addition to this revision of the law, the Japanese version of the Vaccine Information Statement (VIS) was released by the Japan Pediatric Society in 2018. The VIS provides useful caregiver information on general immunization concepts and individual vaccines. Further challenges for the Japanese immunization program include (1) administering a booster dose of pertussis-containing vaccine to preschool children or teenagers, (2) reestablishing the active recommendation for human papilloma virus vaccines, (3) adding the mumps and influenza vaccines to the NIP, and (4) ensuring optimal dosing of seasonal influenza vaccines. During the current coronavirus disease 2019 (COVID-19) pandemic, vaccination rates among children have been decreasing in many countries. In Japan, vaccination rates have been stable in infants, but declining among toddlers and school-aged children, despite public awareness of the need for timely administration of vaccines during the pandemic. Clearly, further action is needed if we are to adequately protect children living in Japan from vaccine-preventable diseases.     

腾冲县扩大国家免疫规划疫苗接种率调查分析

目的了解腾冲县扩大国家免疫规划（National Immunization Program,NIP）疫苗的接种现状,分析存在问题,促进免疫规划工作的可持续发展。方法采用容量比例概率抽样方法抽取30个村,每个村随机调查1~2岁儿童14人,共调查420名儿童NIP疫苗的基础免疫（初种）及加强免疫（复种）情况。结果建预防接种卡率100%,建预防接种证率100%,预防接种卡、证符合率68.57%。调查儿童卡介苗、口服脊髓灰质炎减毒活疫苗、白喉-破伤风-百日咳联合疫苗（Diphtheria,Tetanus and Pertussis Combined Vaccine;DTP）、首剂含麻疹成分疫苗（First Dose Measles-containing Vaccine,MCV1）、乙型肝炎疫苗（以上五种NIP疫苗简称＂五苗＂）基础免疫（初种）全程接种率为98.57%,合格接种率为82.38%;加强免疫（复种）第4剂（Fourth Dose）DTP（DTP4）、第2剂（Second Dose）MCV（MCV2）免疫接种率分别为91.09%、92.25%,合格接种率分别为86.82%、89.92%。NIP新增疫苗A群脑膜炎球菌多糖疫苗（Group A Meningococcal Polysaccharide Vaccine,MPV-A）、首剂流行性乙型脑炎减毒活疫苗（First Dose Japanese Encephalitis Attenuated Live Vaccine,JEV-L1）、甲型肝炎减毒活疫苗基础免疫（初种）接种率分别为92.38%、97.38%、92.98%,合格接种率为84.52%、83.10%、80.95%;第二剂（Second Dose）JEV-L（JEV-L2）接种率为92.25%,合格接种率为79.53%。不合格接种的前三位原因是漏种/未完成全程接种、提前接种、超期接种;主要不合格接种疫苗为JEV-L、MPV-A、MCV、DTP。结论腾冲县NIP非新增疫苗基础免疫（初种）接种率﹥99%,加强免疫（复种）及NIP新增疫苗接种率﹥90%,但合格接种率相对较低,要在保持和提高接种率的同时,提高合格、有效接种是核心。     

我国二类疫苗集中采购程序及核心要素分析

目的：分析二类疫苗集中采购的基础性政策,揭示疫苗采购的主要程序与核心要素,以期提出优化建议。方法：运用内容分析法,进行词频统计与共现网络构建,结合对比分析法,总结各省份二类疫苗采购的共性与差异。结果：我国二类疫苗集中采购程序包括规划、遴选、执行,共涉及采购目录、采购公告、疫苗接收与购入等17个核心要素。其中,集中采购周期以1年为主,疫苗报价大部分参考各省份的价格水平,定标时主要采取评审模式。结论：各省份二类疫苗集中采购程序与框架一致,采购环境趋于公开、规范,应完善二类疫苗监测与评价、深化遴选标准、健全评审人才队伍等,促进我国二类疫苗采购良性发展。     

Trust collapse caused by the Changsheng vaccine crisis in China

BackgroundThe public acceptance and implementation of vaccination programs is essential to prevent infectious diseases. However, vaccine adverse events may cause public panic and eventually lead to an increasing number of populations who were hesitant or refuse to participate in these vaccination programs. In 2018, the Changsheng vaccine crisis broke out in mainland China, and 252,600 unqualified DTP vaccines were reported to be used for child vaccination. In this study, we observed media and public reactions toward the vaccine crisis.MethodsThis study conducted Internet surveillance by four mainstream indicators from July 15th to August 7th, including social media (WeChat, Sina Weibo), online news and Baidu search index. We also analyzed the emotional perceptions of people in crisis through an online questionnaire survey.ResultsDuring the crisis, huge number of articles emerged on Internet, 125,882,894 articles (including forwarding) on WeChat friends circle, 1,877,660 Sina Weibo posts, 648,265 online news and 4,986,521 Baidu search indexes. Most of these articles were negative and expressed the public’s weak confidence to the China-made vaccines. Public confidence in vaccines was undermined by the actions of the manufacturer and the government.ConclusionsThe DTP vaccine crisis led to panic about immunization and eroded trust in the immunization program and in the government. Restoring public confidence in Chinese-made vaccines will take a long time, and meticulous management in vaccine production, and strict government regulation will help to alleviate public anxiety about vaccine safety and ultimately restore confidence.     

Cost-benefit analysis of rotavirus vaccine included in the national immunization program in China

BackgroundGlobally, rotavirus is a leading cause of severe acute gastroenteritis among children aged under 5 years and has a significant economic cost. Currently, rotavirus vaccines are only included in the private market in China. This study aimed to assess the cost-benefit of including a three-dose rotavirus vaccine in China’s National Immunization Program (NIP).MethodsA decision tree Markov model was constructed to evaluate the cost-benefit of universal immunization with three doses of rotavirus vaccine for a 2019 birth cohort of Chinese children. Costs of the universal vaccination program included vaccine price, vaccine wastage, vaccine administration, and indirect costs. All costs were discounted at 3 % per year and converted from 2019 Chinese Yuan to 2019 USD using the 2019 exchange rate.ResultsFor the 2019 birth cohort of Chinese infants, inclusion of RotaTeq in NIP was estimated to prevent 5,677,911 cases of rotavirus infection, with net savings of $1.1 billion in total societal costs. A cost of $17.55 per vaccine dose was the threshold at which inclusion of rotavirus vaccine in NIP would be cost-saving.ConclusionsIntroducing rotavirus vaccine into the China NIP would have significant costs from a societal perspective at the current private market price.     

Monitoring vaccine safety using the vaccine safety Datalink: Assessing capacity to integrate data from Immunization Information systems

BackgroundThe Vaccine Safety Datalink (VSD) uses vaccination data from electronic health records (EHR) at eight integrated health systems to monitor vaccine safety. Accurate capture of data from vaccines administered outside of the health system is critical for vaccine safety research, especially for COVID-19 vaccines, where many are administered in non-traditional settings. However, timely access and inclusion of data from Immunization Information Systems (IIS) into VSD safety assessments is not well understood.MethodsWe surveyed the eight data-contributing VSD sites to assess: 1) status of sending data to IIS; 2) status of receiving data from IIS; and 3) integration of IIS data into the site EHR. Sites reported separately for COVID-19 vaccination to capture any differences in capacity to receive and integrate data on COVID-19 vaccines versus other vaccines.ResultsAll VSD sites send data to and receive data from their state IIS. All eight sites (100%) routinely integrate IIS data for COVID-19 vaccines into VSD research studies. Six sites (75%) also routinely integrate all other vaccination data; two sites integrate data from IIS following a reconciliation process, which can result in delays to integration into VSD datasets.ConclusionsCOVID-19 vaccines are being administered in a variety of non-traditional settings, where IIS are commonly used as centralized reporting systems. All eight VSD sites receive and integrate COVID-19 vaccine data from IIS, which positions the VSD well for conducting quality assessments of vaccine safety. Efforts to improve the timely receipt of all vaccination data will improve capacity to conduct vaccine safety assessments within the VSD.     

Vaccine events raising public concern and associated immunization program policy and practice changes,China, 2005–2021

IntroductionSeveral vaccine events causing public concern have occurred in China that were investigated and responded to by the central government. We describe causes, influences, and policy or practice changes associated with vaccine events that occurred between 2005 and 2021. We make recommendations to foster resilience in China’s Expanded Program of Immunization (EPI) system and vaccination enterprises and to sustain vaccine and program confidence.MethodsOur study included all vaccine events since 2005 that were investigated and responded to by the central government of China. We verified mainstream and social media visibility of the events through Internet search. We extracted event times, causes, investigation processes, results, actions, and policy or practice regulation changes from official reports of government meetings and from official websites with media briefings.ResultsSeven vaccine events were identified, each of which caused more than 100,000 mainstream or social media reports nationally or nationally and internationally. The events ranged in magnitude from 145 children receiving out-of-date oral poliovirus vaccine to a measles supplementary immunization activity involving 103 million children. Few, if any, children were directly harmed by vaccines in the events. Government responded to each event with program or policy changes, and in one case, with legislation. Responses affected the conduct of campaigns and supplementary immunization activities, use of schools as vaccination venues, financial incentives for vaccinating with non-program vaccines, vaccine procurement and distribution, and program policy making. The most fundamental response was enacting the country’s first vaccine law, the 2019 Vaccine Administration Law, which guides virtually all aspects of vaccination work, from vaccine development through regulation, program implementation, and safety and impact monitoring.ConclusionsAll seven events generated substantial national and international mainstream and social media criticism and discussion, most commonly expressed through concerns of vaccine safety or vaccine effectiveness. Most had temporally associated temporary declines in vaccine confidence and coverage, jeopardizing decades of vaccination effort. The central government responded to each event by attempting to address root causes. Faithful implementation of the Vaccine Administration Law is fundamental to program strengthening and sustaining confidence of families, stakeholders, and government in vaccines and immunization in China.     

2011-2019年中国B型流感季节性、年龄特征和疫苗匹配度分析

目的 分析2011-2019年中国B型流感的季节性、年龄分布以及与疫苗的匹配程度,为今后B型流感的监测和疾病负担评价、四价流感疫苗应用、免疫策略制定提供证据。方法 利用全国流感监测网络2011年第14周至2019年第13周的流行病学和病原学监测数据,绘制热图、进行描述性统计,分析B型流感季节性和年龄分布特征。利用流感周报公布的抗原性分析结果,分析B型流感流行株与疫苗毒株的匹配情况。结果 2011-2019年中国B型流感呈现明显的季节性特征,在6个冬春季和A型共同流行,且B/Victoria和B/Yamagata系交替流行,部分南方地区在个别年度出现B型2个系共同流行。B型流感的年龄分布呈双峰,2个系的病毒均在5～15岁组阳性率最高,10岁为峰值;B/Victoria系病毒在25～35岁组为次高峰;B/Yamagata系病毒在55～65岁组为次高峰。B型流感流行株在2015-2016、2017-2018年度与三价流感疫苗所含B型系别不匹配,在2011-2012、2012-2013、2013-2014、2014-2015、2016-2017年度与疫苗所含B型系别匹配,2018-2019年度与疫苗所含B型系别匹配但抗原性中等程度匹配,交叉反应性低。结论 中国B型流感主要在冬春季流行,强度低于A型流感,不同系病毒的年龄分布存在差异,B型流感流行株与疫苗株多个季节不匹配,需持续开展B型流感的监测和疾病负担评价,完善疫苗免疫策略,提高流感疫苗接种率,降低流感对高危人群的危害。     

新疆维吾尔自治区2016－2017年免疫规划疫苗损耗调查

目的 了解新疆维吾尔自治区预防接种单位免疫规划（EPI）疫苗的损耗现状，为进一步精细化管理和使用EPI疫苗提供依据。方法 采取分层整群抽样方法抽取135个接种单位，调查2016-2017年6种EPI疫苗接种和使用数据，包括常规免疫和脊髓灰质炎疫苗群体性补充免疫活动中疫苗领发和使用数量、疫苗报废记录，以及接种单位的地区类型、服务模式、接种周期、日均接种量等。采用描述流行病学方法计算和分析疫苗的损耗系数。结果 单人份的无细胞百白破联合疫苗（DTaP）和三价脊髓灰质炎减毒活疫苗（tOPV）损耗系数最低，分别为1.00和1.02；多人份的二价脊髓灰质炎减毒活疫苗（bOPV）、A群脑膜炎球菌多糖疫苗（MPV-A）、白喉破伤风联合疫苗（DT）、卡介苗（BCG）损耗系数分别为1.58、1.67、1.68、3.02。城市、农村、牧区接种单位EPI疫苗损耗系数范围分别为1.00~2.84、1.00~3.71、1.00~2.27；乡级集中、村级集中、分散接种模式的损耗系数分别为1.00~3.00、1.00~4.41、1.00~1.94。接种周期越长或日均接种量越小，损耗系数越大。结论 新疆维吾尔自治区预防接种单位多人份EPI疫苗损耗较高，并受地区和接种服务形式的影响。需根据地区类型、接种单位服务形式等加强精细化的疫苗管理，减少疫苗损耗和浪费。     

全国2007～2008年疑似预防接种异常反应监测分析

目的分析全国（未包括香港、澳门特别行政区和台湾地区,下同）疑似预防接种异常反应（Adverse EventsFollowing Immunization,AEFI）的发生特征,评价AEFI监测系统运转情况,国家免疫规划（National ImmunizationProgram,NIP）疫苗的安全性和预防接种服务质量。方法通过中国免疫规划监测信息管理系统和儿童预防接种信息管理系统,收集全国截止2009年3月25日报告的2007～2008年个案数据,采用描述性方法,对相关指标进行流行病学分析。结果全国2007～2008年报告AEFI32120例,其中95.02%来自10个试点省（自治区、直辖市,下同）。32120例中,男女性别比为1.41：1,≤1岁儿童占77.53%,集中发生在4～10月。发生AEFI前三位的疫苗为百日咳-白喉-破伤风联合疫苗、脑膜炎球菌多糖疫苗、流行性乙型脑炎疫苗,接种第1～2剂次发生的占65.86%,接种≤1d发生的占75.05%。10个试点省NIP疫苗估算报告发生率在7.99/100万剂～322.77/100万剂。AEFI分类诊断中,一般反应占79.93%,异常反应占14.65%,其他〈5%。临床损害前三位为过敏反应、无菌性脓肿、BCG接种异常反应。91.2%的病例治愈或好转,仅1.93%的人住院,2/3的人住院时间≤10d。结论总体上,全国AEFI监测的完整性和敏感性比2005～2006年有所提高,但仍需提高监测质量。AEFI主要发生的疫苗为NIP疫苗,尤其是扩大国家免疫规划新增疫苗;AEFI集中在小年龄组、首剂接种以及接种早期。试点监测显示,NIP疫苗安全性和预防接种服务质量良好。     

Current issues with the immunization program in Japan: Can we fill the “vaccine gap”?

The "vaccine gap" is a term which has been used in Japan to indicate that the current immunization program is behind compared to the programs in other developed countries. The current national immunization program (NIP) which was established under the Japanese Immunization Law includes only six vaccines (eight targeted diseases), and the rest of available vaccines have been categorized as voluntary vaccines, which require out-of-pocket expense in order for the patients to receive them. This has led the vaccination rates for the voluntary vaccines remaining low, and the incidence of the target diseases remaining high. In addition, there are a few domestic rules that exist for immunizations including (1) subcutaneous injection is the standard method of vaccination, (2) the thigh is not considered to be the common site of vaccination in infants, and (3) the intervals of administration of inactivated and live vaccines are strictly determined by law. Along with the "vaccine gap" and the domestic rules, some movements to improve our current NIP are underway; including increased calls to change the NIP from civilians and professionals, the establishment of a group by the representatives from 13 medical professional societies asking the government to consider the immunization policy a "national policy" and seeking the establishment of a new and reorganized national immunization technical advisory group (NITAG). In addition, the Vaccination Subcommittee of Health Sciences Council was formed in the government to reform the current Immunization Law and NIP, which established a new national program for three voluntary vaccines funded by a temporary budget. We hope these new movements will fill the "vaccine gap" and that the NITAG will help ensure that vaccine policy becomes a national policy, and will provide necessary vaccinations without out-of-pocket expense to protect children in Japan from vaccine preventable diseases.