2011-2012年华泾镇预防接种不良反应监测分析

目的：了解华泾镇2011—2012年预防接种后不良反应发生情况。方法：根据WHO对AEFI的定义与分类,收集华泾镇2011-2012年AEFI监测和接种率监测数据,进行描述统计。结果：共报告AEFI65例,发生率为141．70／10万。一般反应57例,占AEFI总病例数的87．69％;异常反应8例,占12．31％。19种疫苗中有13种出现不良反应,其中百白破疫苗的报告发生率最高,为493．33／10万,其次为肺炎疫苗,为369．78／10万。结论：2011-2012年华泾镇AEFI监测系统运转良好,今后需进一步探讨AEFI主动监测模式,提高疫苗安全性监测的敏感性。     

新生儿卡介苗接种情况及护理对策

目的了解深圳某大型综合性医院出生新生儿卡介苗接种、未接种原因及疑似预防接种不良反应的发生情况,并提出护理对策。方法收集2010至2012年深圳市人民医院出生新生儿卡介苗接种及疑似不良反应报告资料。结果2010—2012年深圳市人民医院出生18692名新生儿,新生儿卡介苗接种率为94．4％,随着年份增加,卡介苗接种率有逐年升高的趋势,差别有统计学意义（X2=17．67,P=0．000）。三年中仅发生1例一般反应（发热为38．7℃）。三年在医院住院期间有1056人未接种卡介苗,未接种原因主要是早产、低体重、新生儿窒息,分别占61．1％、21．2％、10．2％,还有呼吸困难、黄疸、畸形、贫血、先天性心脏病等共占7．5％。结论深圳市人民医院住院分娩的新生儿卡介苗接种率较高,疑似预防接种不良反应发生率较低,未接种原因主要是对禁忌症把握过严,需加强预防接种工作人员的培训。     

Subcutaneous nodules following immunization in children; in Victoria,Australia from 2007 to 2016

BackgroundSubcutaneous nodules are a rare adverse event following immunization (AEFI). We aimed to describe nodules at the injection site reported to SAEFVIC (Surveillance of Adverse Events Following Vaccination in the Community) using the Brighton Collaboration Case Definition (BCCD), management and recurrence following subsequent immunizations.MethodWe assessed 58 cases (<18 years of age) of ‘nodule at injection site’ reported to SAEFVIC, Melbourne, Australia, between May 2007 and June 2016. Case details were analyzed from records and phone interview follow-up. The Australian Immunization Registry was reviewed for immunization status.Results71% (41/58 reported cases) were consistent with the BCCD for subcutaneous nodule, 14% (8 cases) were ‘possible subcutaneous nodules’, 10% (6 cases) were nodules associated with BCG immunization and 5% (3 cases) were attributable to an alternative diagnosis. The median age at immunization was 12 months, (range 1 month–12 years); 54% male (22/41 cases). 17% (7 cases) had multiple nodules. Nodules were associated with immunizations containing aluminum (74%, 36/49 nodules), no aluminum (8%, 4 nodules) and unknown (18%, 9 nodules). Most cases developed symptoms within 3 days post-immunization (59%, 24 cases) and in the thigh (59%, 29 nodules). Pruritus was associated in 41% (17 cases). Around 1/3 (34%) of nodules resolved 6 months post immunization, 2/3 (68%) by 12 months, however 1/4 (24%) remained persistent for >24 months. 5 cases had prior nodules and 1 case had recurrence with subsequent immunization. 83% (34 cases) were fully immunized for age at follow-up.ConclusionSubcutaneous nodules at the injection site may occur following a wide range of vaccines, including vaccines without aluminum. All cases require careful review and where possible, specialist management and to support subsequent immunizations.     

Immunization in pregnancy safety surveillance in low and middle-income countries- field performance and validation of novel case definitions

BackgroundA globally standardized approach in high and low and middle-income countries (LMIC) to actively monitor the safety of vaccines for pregnant women during development and implementation phases is critical. Brighton Collaboration’s (BC) Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project has developed globally standardized case definitions (CDs) of key obstetric and neonatal terms for the assessment of safety of vaccines in pregnancy. CDs are categorized into levels of diagnostic certainty, facilitating their use in varied settings. This study evaluates the field performance of CDs in LMIC.MethodsData from pregnant participants of RCTs for trivalent inactivated influenza vaccine conducted at Chris Hani Baragwanath Academic Hospital, South Africa (SA) between 2011 and 2013 were reviewed retrospectively for preterm birth, stillbirth and hypertension CDs and the Gestational age assessment (GA) algorithm. Data from an ongoing pneumococcal vaccine trial (conducted at MRC Unit, The Gambia) were collected prospectively for GA.ResultsFor GA, 600 mother-infant dyads from Gambia and 155 mother-infant dyads from SA were reviewed. Level 2B (unsure LMP and US in 2nd trimester) was the most common level seen in Gambia (63%) and level 3B1 (unsure LMP with physical examination) in SA (43%). Preterm deliveries had similar results in SA. The pregnancy-induced hypertension definition performed well, with 96% (54/56) of cases fulfilling ‘level 1’ for ‘preeclampsia with severe features’. 24 stillbirths were identified and 21 records were reviewed; 73.3% (11/15) of the stillbirths classified as antepartum by attending physicians and 83.3% (5/6) of the intrapartum stillbirths did not fulfil the criteria for any level of certainty.ConclusionBC CDs for neonatal and maternal outcomes (preterm and hypertension) and GA were sensitive, reliable and feasible to use in RCTs in SA and Gambia. Modifications to the stillbirth CD are required to improve its usefulness in varied settings.     

2015—2017年宝安区福永街道疑似预防接种异常反应监测分析

目的分析2015—2017年宝安区福永街道疑似预防接种异常反应(AEFI)监测资料,评价AEFI监测系统运转情况,为今后AEFI监测及处置工作开展提供参考依据。方法用描述流行病学方法对2015—2017年宝安区福永街道AEFI监测资料进行分析和评价。结果 2015—2017年全街道共报告AEFI个案397例,报告发生率为47.27/10万,一般反应占70.03%;2017年福永街道与宝安区的AEFI个案报告种类构成存在差异;引起AEFI的主要疫苗是无细胞百白破疫苗,占总数的25.43%;AEFI个案报告主要以0岁组和1岁组为主,分别占49.37%和28.46%;每年的上报高峰均为第二季度;48 h报告率、48 h调查率3年均在99.00%以上。结论福永街道AEFI监测系统运转尚可,但三年来AEFI报告数呈现小幅下降趋势,仍需采取措施进一步改善。     

The Intensive Vaccines Monitoring Programme (IVMP): an electronic system to monitor vaccine safety in New Zealand

New Zealand introduced a tailor-made vaccine (MeNZB™) for epidemic control of Group B meningococcal disease. The Intensives Vaccine Monitoring Programme (IVMP), which prospectively collected data electronically on a cohort of children receiving vaccinations in sentinel practices across NZ, was developed as part of a national multi-faceted safety strategy. The main aim of the IVMP was to identify the presence of unexpected adverse events occurring with MeNZB™ vaccination. We describe the methodology and success factors plus consider the limitations encountered in this system which shows potential as a means for post-marketing vaccine and medicine surveillance in the future.     

2009-2014年天津市河西区疑似预防接种异常反应 监测结果分析

摘要:目的　探讨2009-2014年天津市河西区预防接种不良反应监测系统报告的不良反应问题,为疫苗安全使用提供科学依据。方法　采取描述流行病学得方法对河西区监测系统收集的AEFI病例分析。结果　2009-2014年河西区通过AEFI信息管理系统接报15种疫苗引起的AEFI病例208例,总报告接种剂次为778172剂,AEFI发生率为26.73/10万,12个社区卫生服务中心均有AEFI病例发生。常见临床症状为发热、接种局部红肿及硬结。较为严重有两例,均为接种吸附无细胞百白破疫苗后,一例为血管性水肿、另一例为血小板过敏性紫癜。结论　全区12个社区卫生服务中心均有AEFI病例发生,AEFI报告发生率很低,预防接种的安全性良好。AEFI监测是科学评价接种疫苗的利弊,及时处置AEFI,增加大众对预防接种信心的有效措施。     

Systematic causality assessment of adverse events following HPV vaccines: Analysis of current data from Apulia region (Italy)

Since 2013, World Health Organization (WHO) recommended that adverse events following immunization (AEFIs) should be evaluated by a standardized algorithm for causality assessment, however the use of WHO procedure is rarely adopted. In Italy, AEFIs (classified only by temporal criteria) are registered in the National Drug Authority (AIFA) database, but causality assessment is not mandatory. Every year AIFA publishes the AEFIs report, that doesn’t contain information about causal correlation between events and vaccines. From AIFA database, we selected AEFIs following human papillomavirus vaccination (HPV) reported in Apulia (about 4,000,000 inhabitants) during 2008–2016. For serious AEFIs, we applied WHO causality assessment criteria; for cases hospitalized, we repeated the assessment getting additional information from health documentation. In 2008–2016, 100 HPV AEFIs (reporting rate: 17.8 per 100,000 doses) were registered of which 19 were serious (rate: 3.4 per 100,000 doses) and 12 led to hospitalization. After causality assessment, for 9 AEFIs the classification was “consistent causal association to immunization”, for 3 indeterminate, for 5 “inconsistent causal association to immunization” and for 2 not-classifiable. Among hospitalized patients, 5 AEFIs were consistent, 5 inconsistent, 1 not-classifiable and 1 indeterminate; adding information from health documentation, the results were similar except for indeterminate and not classifiable AEFIs that turned into “not consistent”. Only half of severe AEFIs could be associated with vaccination and this suggests that AIFA report provides a incomplete picture of HPV vaccine safety, with a risk for readers to confound “post hoc” and “propter hoc” approach without considering the causality assessment results. In the view of the systematic use of WHO causality assessment algorithm in the AEFI surveillance, the efforts of Public Health must be focused on the improvement of the quality of the information provided to reduce conclusions inter-observer variability; the routine follow-up of reports, also to collect additional information, must be guaranteed.     

The association of adverse events with bivalent human papilloma virus vaccination: A nationwide register-based cohort study in Finland

BackgroundA bivalent HPV vaccine (Cervarix®; HPV2, GlaxoSmithKline) was introduced into the Finnish national vaccination programme (NVP) in November 2013 for girls aged 11–13 years with a catch-up for 14–15 year-olds. We evaluated the association between HPV2 and selected autoimmune diseases and clinical syndromes by conducting a nation-wide retrospective register-based cohort study.MethodsFirst life-time occurrences of the relevant ICD-10 codes in girls aged 11–15 years between Nov-2013 and Dec-2016 were obtained from the national hospital discharge register. Population denominators were obtained from the Population Information System and vaccination records from the National Vaccination Register. Registers were linked using unique personal identity codes. Association between HPV2 and 38 selected outcomes were studied using Cox regression, with age as the main time-scale and the first vaccination dose as the time-dependent exposure. The hazard ratios (HR) with 95%CI were assessed according to the time since exposure (entire follow-up, 0-180/181-365/>365 days).ResultsOf 240 605 girls eligible for HPV2 vaccination, 134 615 (56%) were vaccinated. After adjustment for geographical area (6 hospital districts), country of origin (Finnish-born/not) and number of hospital contacts from 9 through 10 years of age, HRs ranged from 0.34 (95%CI 0.11–1.05) to 8.37 (95%CI 0.85–82.54) and HPV2 vaccination was not statistically significantly associated with a higher risk of any outcome during the entire follow-up.ConclusionsThis study found no significantly increased risk for the selected outcomes after the HPV vaccination in girls 11–15 years of age. These results provide valid evidence to counterbalance public scepticism, fears of adverse events and possible opposition to HPV vaccination and consequently can contribute to increase HPV vaccination coverage in Finland as well as elsewhere.     

Anxiety-related adverse events following immunization (AEFI): A systematic review of published clusters of illness

BackgroundClusters of anxiety-related adverse events following immunization (AEFI) have been observed in several countries and have disrupted country immunization programs. We conducted a systematic literature review to characterize these clusters, to generate prevention and management guidance for countries.MethodsWe searched seven peer-reviewed databases for English language reports of anxiety-related AEFI clusters (≥2 persons) with pre-specified keywords across 4 categories: symptom term, cluster term, vaccine term, and cluster AEFI phenomenon term/phrase. All relevant reports were included regardless of publication date, case-patient age, or vaccine. Two investigators independently reviewed abstracts and identified articles for full review. Data on epidemiologic/clinical information were extracted from full text review including setting, vaccine implicated, predominant case-patient symptoms, clinical management, community and media response, and outcome/impact on the vaccination program.ResultsOf 1472 abstracts reviewed, we identified eight published clusters, from all six World Health Organization (WHO) regions except the African Region. Seven clusters occurred among children in school settings, and one was among adult military reservists. The size and nature of these clusters ranged from 7 patients in one school to 806 patients in multiple schools. Patients’ symptoms included dizziness, headache, and fainting with rapid onset after vaccination. Implicated vaccines included tetanus (2), tetanus-diphtheria (1), hepatitis B (1), oral cholera (1), human papillomavirus (1), and influenza A (H1N1)pdm09 (2). In each report, all affected individuals recovered rapidly; however, vaccination program disruption was noted in some instances, sometimes for up to one year.ConclusionsAnxiety-related AEFI clusters can be disruptive to vaccination programs, reducing public trust in immunizations and impacting vaccination coverage; response efforts to restore public confidence can be resource intensive. Health care providers should have training on recognition and clinical management of anxiety-related AEFI; public health authorities should have plans to prevent and effectively manage anxiety-related AEFI clusters. Prompt management of these occurrences can be even more important in an era of social media, in which information is rapidly spread.