Annual report: surveillance of adverse events following immunisation in Australia, 2010

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2010, and describes reporting trends over the 11-year period 2000 to 2010. There were 3,894 AEFI records for vaccines administered in 2010, the highest number reported in any year, and a 63% increase over the 2,396 in 2009. The increase was almost entirely attributable to the large number of reports following seasonal influenza (n = 2,354) and pandemic H1N1 (pH1N1) influenza vaccines (n = 514). In children < 7 years of age, the number of reports following influenza vaccine increased almost 100-fold from 17 in 2009 to 1,693 in 2010 and, for people aged > or =18 years, from 135 to 496. For seasonal influenza vaccine, a disproportionate number of reports were from Western Australia (34%), consistent with more widespread influenza vaccination of children in that state, and 79% were identified as being associated with Fluvax or Fluvax junior (CSL Biotherapies). For pH1N1 vaccine, the number of reports in children < 7 years of age increased from 23 in 2009 to 329 in 2010, but was available for this age group for only 1 month (December) in 2009. In those aged > or = 18 years, for whom the pH1N1 vaccine was available from late September 2009, pH1N1 vaccine reports decreased from 1,209 in 2009 to 109 in 2010. For influenza vaccines, 79% of reports included fever, 45% allergic reactions and 15% malaise. In children aged < 7 years, there were 169 reports of convulsions (127 febrile), compared with 19 in 2009. In contrast, for non-influenza vaccines, reporting rates in children < 7 years of age increased only marginally from 14.1 per 100,000 in 2009 to 19.3 per 100,000 in 2010. Four deaths temporally associated with immunisation were reported but none were considered to have a causal association.     

Annual report: surveillance of adverse events following immunisation in Australia, 2004

This report summarises Australian passive surveillance data on adverse events following immunisation (AEFI) for 2004 and describes reporting trends over the five years, 2000 to 2004. AEFIs are notified to the Adverse Drug Reactions Advisory Committee by state and territory health departments, hospitals, doctors and other health providers, vaccine manufactures, and the public. There were 975 AEFI records for vaccines received in 2004. This is an annual AEFI reporting rate of 4.8 per 100,000 population, the lowest since 2000, and a 33 per cent decrease compared with 2003 (1,460 records; 7.1 AEFI records per 100,000 population). Dose-based AEFI reporting rates in 2004 were 1.8 per 100,000 doses of influenza vaccine for adults aged > or = 18 years and 11.8 per 100,000 doses of scheduled vaccines for children aged < 7 years. The majority of records described non-serious events while nine per cent (n = 88) described AEFIs defined as 'serious'. There were no reports of death related to immunisation. The most frequently reported individual AEFI was injection site reaction in children following a fifth dose of an acellular pertussis-containing vaccine (67 reports per 100,000 doses). The marked reduction in the AEFI reporting rate in 2004 coincided with the removal of the fourth dose of acellular pertussis vaccine, due at 18 months of age, from the vaccination schedule in September 2003 and fewer people receiving meningococcal C vaccine through the national catch-up vaccination program for those aged 1-19 years in 2004, compared with 2003. The consistently low reporting rate of serious AEFIs demonstrates the high level of safety of vaccines in Australia.     

Annual report: surveillance of adverse events following immunisation in Australia, 2009

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2009, and describes reporting trends over the 10-year period 2000 to 2009. There were 2,396 AEFI records for vaccines administered in 2009, the highest number reported, a 46% increase over the 1,638 in 2008. The increase was almost entirely due to reports related to the introduction of pandemic H1N1 (pH1N1) 2009 influenza vaccine from September 2009 (n = 1,312) largely from the members of the public. The pH1N1 AEFI reporting rate for people aged > or = 18 years was 34.2 per 100,000 administered doses compared with 2.8 for seasonal influenza vaccine. The rates in > or = 65 year-olds were 28.0, 1.6 and 13.3 for pH1N1, seasonal influenza and polysaccharide pneumococcal, respectively. The high reporting rate for pH1N1 vaccine is likely to be at least partly due to enhanced reporting seen for all new vaccines and greater levels of reporting from members of the public in response to the implementation of strategies to encourage reporting, as part of the pH1N1 program. For children < 7 years, AEFI reporting rates in 2009 (14.1 per 100,000 administered doses) were similar to previous years. There were 193 (8%) AEFI reports classified as serious; 6 deaths temporally associated with immunisation were reported but none were judged to have a causal association. As in previous years, the most commonly reported reactions were allergic reaction, injection site reaction, fever, headache, malaise, nausea and myalgia. The most commonly reported reactions following pH1N1 influenza vaccine were allergic reaction (n = 381), headache (n = 289), fever (n = 235), pain (n = 186), nausea (n = 180) and injection site reaction (n = 178). The data within the limitation of passive surveillance provide a reference point for ongoing reporting of trends in AEFI by age group, severity and vaccine type and illustrate the value of the national TGA database as a surveillance tool for monitoring AEFI nationally.     

Annual report: Surveillance of adverse events following immunisation in Australia, 2005

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Adverse Drug Reactions Advisory Committee for 2005, and describes reporting trends over the six year period 2000 to 2005. There were 839 AEFI records for vaccines received in 2005. This is an annual AEFI reporting rate of 4.1 per 100,000 population, the lowest since 2000 and a 22 per cent decrease compared with 2004 (1,081 records; 5.4 AEFI records per 100,000 population). The decrease was not consistent across age groups. Reporting of AEFI increased for children aged <1 year in 2005 (60.7 versus 50.3 per 100,000 population) and decreased for the 7 to <20 year age group (0.9 versus 8.9 per 100,000 population). Dose-based AEFI reporting rates in 2005 were 11.0 per 100,000 doses of scheduled vaccines for children aged <7 years and 2.0 per 100,000 doses of influenza vaccine for adults aged >18 years. The majority of records described non-serious events while 9 per cent (n=72) described AEFIs defined as serious. There was one report of death in an older person following influenza vaccine and one of non-polio acute flaccid paralysis in an infant, both temporally associated with immunisation. The most frequently reported individual AEFI was injection site reaction in children following a fifth dose of diphtheria-tetanus-acellular pertussis vaccine (79 reports per 100,000 doses). The increase in the population-based AEFI reporting rate for children aged <1 year in 2005 coincided with the introduction of national immunisation programs for conjugate pneumococcal vaccine in January 2005 and inactivated poliovirus vaccine in November 2005. The fall in reporting rates for older children and adolescents follows the completion of the national meningococcal C catch-up program in early 2005. The consistently low reporting rate of serious AEFIs demonstrates the high level of safety of vaccines in Australia.     

Continuous active surveillance of adverse events following immunisation using SMS technology

IntroductionOn-going post-licensure surveillance of adverse events following immunisation (AEFI) is critical to detecting and responding to potentially serious adverse events in a timely manner. SmartVax is a vaccine safety monitoring tool that uses automated data extraction from existing practice management software and short message service (SMS) technology to follow-up vaccinees in real-time. We report on childhood vaccine safety surveillance using SmartVax at a medical practice in Perth, Western Australia.MethodsParents of all children under age five years who were vaccinated according to the Australian National Immunisation Schedule between November 2011 and June 2015 were sent an SMS three days post administration to enquire whether the child had experienced a suspected vaccine reaction. Affirmative replies triggered a follow-up SMS requesting details of the reaction(s) via a link to a survey that could be completed using a smartphone or the web. Rates of reported AEFI including fever, headache, fatigue, rash, vomiting, diarrhoea, rigours, seizures, and local reactions were calculated by vaccination time point.ResultsOverall, 239 (8.2%; 95% CI 7.2–9.2%) possible vaccine reactions were reported for 2897 vaccination visits over the 44 month time period. The proportion of children experiencing a possible AEFI, mostly local reactions, was significantly greater following administration of diphtheria–tetanus–pertussis–poliomyelitis vaccine at 4 years of age (77/441; 17.5%; 95% CI 13.9–21.0%) compared to the vaccinations given at 2–18 months (p < 0.001). Across all time points, local reactions and fatigue were the most frequently reported AEFI.ConclusionAutomated SMS-based reporting can facilitate sustainable, real-time, monitoring of adverse reactions and contribute to early identification of potential vaccine safety issues.     

Surveillance of adverse events following immunisation: Australia, 2000-2002.

The Adverse Drug Reactions Advisory Committee (ADRAC) database collates notifications of adverse events following immunisation (AEFI) from across Australia. The data were analysed for vaccines received between 1 January 2000 and 30 September 2002. Dose-based AEFI reporting rates were calculated using denominator data from the Australian Childhood Immunisation Register and annual national influenza vaccination coverage surveys. The majority of the 2,409 AEFI records analysed described non-serious events, principally injection site reactions; 10.5 per cent (n = 253) described AEFIs with outcomes defined as 'serious'. Ten deaths were recorded but only one, following yellow fever vaccine, was causally related to immunisation. The average annual population-based reporting rate was 4.5 per 100,000 population. Vaccine dose-based AEFI reporting rates were 2.2 per 100,000 doses of influenza vaccine for adults aged 40 years and over and 14.6 per 100,000 doses of all scheduled vaccines for children aged less than 7 years. The most frequently reported type of adverse event was injection site reaction following receipt of an acellular pertussis-containing vaccine, particularly among children in the age groups scheduled to receive their fourth or fifth doses of the vaccine (overall reporting rate 67 per 100,000 doses). The data highlight the safety of vaccines in Australia, and illustrate both the utility of available immunisation coverage data to estimate dose-based AEFI reporting rates and the value of the ADRAC database as a surveillance tool for monitoring AEFIs nationally.     

Surveillance of adverse events following immunisation: Australia 2002 to 2003.

Reports of suspected adverse events following immunisation (AEFI) are reviewed by the Adverse Drug Reactions Advisory Committee and collated in a central database. We analysed AEFI records for vaccines administered during October 2002 to December 2003, and assessed AEFI reporting trends for 2000 to 2003. AEFI reporting rates were calculated using denominator data from the Australian Childhood Immunisation Register and the annual national influenza vaccination coverage survey. A total of 1,744 AEFI records were analysed for October 2002 to December 2003. The majority described non-serious events; 9 per cent (n=149) described AEFIs defined as 'serious'. Four deaths were reported but none were causally related to immunisation. Dose-based AEFI reporting rates were 2.1 per 100,000 doses of influenza vaccine for adults aged 40 years or over and 19.8 per 100,000 doses of scheduled vaccines for children aged <7 years. The most frequently reported individual AEFI was injection site reaction in children after a fourth or fifth dose of an acellular pertussis-containing vaccine (54 and 98 reports per 100,000 doses respectively). The most frequently suspected vaccine was meningococcal C conjugate vaccine (34% of reports-mostly injection site reactions, gastrointestinal symptoms and headaches). The average annual reporting rate was 7.0 per 100,000 population, the highest to date. The increase in the AEFI reporting rate was due to a greater number of children becoming eligible to receive a fourth or fifth consecutive dose of acellular pertussis vaccine and the introduction of the meningococcal C vaccination program in January 2003 for those aged 1-19 years. The low reporting rate of serious AEFIs demonstrates the high level of safety of vaccines in Australia.     

Comparison of text-messaging to voice telephone interviews for active surveillance of adverse events following immunisation

ObjectivesIn 2013, the Follow-up and Active Surveillance of Trivalent Influenza Vaccine in Mums (FASTMum) program began using short message service (SMS) to collect adverse event information in pregnant women who recently received trivalent influenza vaccine (TIV). This study was designed to compare data collected via SMS and telephone for the purposes of monitoring vaccine safety.MethodsA number of 344 women who received TIV were randomly assigned to a telephone interview group. They were telephoned seven days post-vaccination and administered a standard survey soliciting any adverse events following immunisation (AEFI) they experienced. They were matched by brand of vaccine, age group, and residence to 344 women who were sent a SMS seven days post-vaccination. The SMS solicited similar information. AEFI reported by SMS and telephone interview were compared by calculating risk ratios.ResultsResponse rate was higher to SMS compared to telephone interview (90.1% vs. 63.9%). Women who were surveyed by SMS were significantly less likely to report an AEFI compared to women who were surveyed by telephone (RR: 0.41; 95% CI: 0.29–0.59). The greatest discrepancies between SMS and telephone interview were for self-reported injection site reactions (3.1% vs. 16.8%) and unsolicited (or “other”) events (11.4% vs. 4.1%). Data collected by SMS was significantly timelier.ConclusionsData collection by SMS results in significantly improved response rates and timeliness of vaccine safety data. Systems which incorporate SMS could be used to more rapidly detect safety signals and promote more rapid public health response to vaccine quality issues.     

Surveillance of adverse events following immunisation: the model of SAEFVIC, Victoria

State-based adverse events following immunisation (AEFI) reporting systems in Australia demonstrate marked regional differences in surveillance methodologies and reporting rates. To improve AEFI services in Victoria, Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC) was established in 2007. SAEFVIC comprises a central reporting enhanced passive surveillance system integrated with clinical services. AEFI may be reported by phone, fax or on-line. Immunisation nurse specialists follow up all reports, coupled with physician review as required. Supervised re-vaccination in a hospital environment, when appropriate, helps ensure clinical support for vaccinees, families and health-care providers. The Brighton Collaboration, the Australian Immunisation Handbook and in-house case definitions are used to categorise AEFI reports. In the first 3 years (2007-2010) of operation 3,265 reports were received, describing 4,293 AEFI. The number of reports received increased annually over the 3-year period. Seventy-six per cent of AEFI met one of 52 established case definitions and the remainder were recorded verbatim: 22% of reported AEFI were considered severe. Of 1,086 persons reporting an AEFI in 2009, 356 (36%) attended for a clinical consultation and 325 (83%) were revaccinated, of which 114 were day stay or overnight patients. Enhanced passive AEFI surveillance using integrated clinical services has been shown to improve adverse event reporting with reporting rates in Victoria increasing from 2.6 per 100,000 in 2003 to 13.5 per 100,000 per annum in 2009. This report describes the SAEFVIC service model and summarises outcomes and lessons learnt in the first 3 years of operation.     

2014年广西疑似预防接种异常反应监测分析

目的：了解广西2014年疑似预防接种异常反应（adverse events following immunization,AEFI）的发生特征,评价广西AEFI监测系统运转情况。方法通过疑似预防接种异常反应监测信息管理系统收集2014年广西报告的AEFI 个案数据,采用描述性流行病学方法进行分析。结果2014年广西报告 AEFI 个案1293例,113个县（区、市）均有AEFI数据报告,县级覆盖率为100%,48小时报告率为96.75%,48小时调查率为99.46%。男、女性别比为1.71∶1;按广西2014年免疫规划信息系统中疫苗接种剂次估算,总的报告发生率为5.00/10万剂次,非严重AEFI报告发生率为4.87/10万剂次,严重AEFI 报告发生率为0.14/10万剂次。预防接种异常反应报告发生率为1.56/10万剂次。异常反应的临床诊断以过敏性皮疹、卡介苗淋巴结炎为主。在所有的AEFI中,治愈和好转的占99.30%。结论广西的AEFI 监测系统运转正常.要加强 AEFI 因果关联评估、分类及处理等相关知识的培训工作,确保 AEFI 监测数据的质量。     

Active SMS-based surveillance of adverse events following immunisation with influenza and pertussis-containing vaccines in Australian pregnant women using AusVaxSafety

BackgroundMaternal immunisation is important to protect both mother and baby, but safety concerns can lead to low uptake. AusVaxSafety participant-based surveillance actively monitors adverse events following immunisation (AEFI) in Australia. We aimed to analyse AEFI in the days following vaccination with seasonal inactivated influenza vaccine (IIV) and/or reduced antigen diphtheria-tetanus-acellular pertussis vaccine (dTpa) in pregnant women in Australia.MethodsDe-identified AEFI reports were solicited from vaccine recipients via automated SMS survey (using SmartVax software) following routine vaccination with IIV and/or dTpa at 219 national sentinel surveillance sites from 2015 to 2018. AEFI rates were compared by vaccine group (IIV alone, dTpa alone, or IIV and dTpa together), vaccine brand, trimester (IIV only) and vaccination period (April to August 2016–2018; IIV only). Women who had two vaccination encounters during surveillance were identified and AEFI rates compared for each dose.ResultsAmong 13,758 participants, overall AEFI rates were lower following IIV (4.9%) than dTpa (6.4%) or IIV and dTpa given concomitantly (7.4%). The AEFI profile was similar for both vaccines, with injection site reactions, tiredness, and headache most commonly reported. Injection site pain and swelling/redness were significantly more common in women who received dTpa than IIV. Reports of medical attendance following immunisation were similar (0.3%) for each vaccine group. AEFI rates did not differ by IIV brand (FluQuadri®, Fluarix® Tetra), dTpa brand (Boostrix®, Adacel®), or by trimester. Among women with sequential dTpa vaccinations, 6.0% (7/116) had an AEFI following their second dTpa dose.ConclusionsSelf-reported AEFI rates did not differ by trimester (IIV), or by vaccine brand (IIV or dTpa). Concomitant influenza and pertussis vaccination was associated with more frequent, but low rates of minor, expected AEFI. These real world ‘citizen science-based’ data provide further reassuring evidence of the safety of maternal vaccination.     

Active surveillance of adverse events following childhood immunization in Singapore

Introduction

In Singapore, reporting of adverse events following immunization (AEFI) was historically passive. In 2009, Health Sciences Authority collaborated with KK Women's and Children's Hospital to perform active surveillance for AEFI. We report the methodology and initial findings of this surveillance following childhood vaccines.

Methods

From April 2010 to March 2012, we screened all paediatric admissions for possible relationships to vaccination, excluding elective admissions, and performed causality assessment for each case using standardized definitions for certain, probable, possible and unlikely. Baseline demographics, data on implicated vaccines and clinical details including severity and outcomes were collected. Total hospital admissions were used to calculate rates of AEFI.

Results

We screened 45,571 (80%) of 56,526 admissions, and evaluated 1988 (4.4%) children. Median age at presentation was 3.1 months, while median interval from vaccination to symptom onset was 6 days. There were 311 (15.6%) children with AEFI that were considered possibly, probably or certainly associated with vaccines. However, 98.8% recovered without any long-term sequelae. The hospital-based active surveillance of AEFI enabled the detection of a 5-fold increase (95% CI 1.2–33.1) in BCG-associated regional lymphadenitis in April 2010, which triggered follow-up safety analysis to guide public health advice.

Conclusions

Hospital-based active surveillance can enhance signal detection and follow-up investigations of AEFI. Subsequently, public health bodies are better equipped to maintain public confidence in vaccination programmes and physicians are able to provide relevant advice to parents. It also allows for a better understanding of risk-benefit ratios of specific vaccines and aids the generation of public health vaccination policy.     

Parental perspectives of vaccine safety and experience of adverse events following immunisation

Introduction

We aimed to determine demographic predictors of parental vaccine safety and risk perceptions, and assess the relationship between the occurrence of children's perceived adverse events following immunisation (AEFI) on parents’ opinions.

Methods

Computer-assisted telephone interviews (CATI) were conducted in 2011 with a cross-sectional, random general population sample of rural and metropolitan residents in South Australia. Multivariate ordinal logistic regression analyses examined associations between parental vaccine safety attitudes and socio-demographic factors, adjusting for whether children had ever experienced a previous suspected AEFI.

Results

Of 469 parents interviewed, 95% were confident in vaccine safety in general, but almost half expressed concern for pre-licensure testing of vaccines. Of all parents, 41% responded that at least one of their children had experienced an AEFI. Almost one third of the AEFI parent group indicated they reported their children's symptoms to either a healthcare professional or the Department of Health. Parental acceptability of the risks of febrile convulsion and anaphylaxis were 73% and 76% respectively. Ordinal logistic regression analyses showed parents of children who had experienced a suspected AEFI were associated with greater concern for vaccine safety (OR:0.53, p ≤ 0.01) and more were likely to expect either a mild or a serious AEFI. After adjusting for demographics, parental confidence in vaccine safety was significantly associated with higher levels of education (OR:2.58, p = 0.01) and being born in Australia OR:2.30, p = 0.004. Mothers, when compared with fathers, were less accepting of the two vaccine risks presented: febrile convulsion (OR:0.57, p = 0.04) and anaphylaxis, (OR:0.55, p = 0.04).

Conclusions

Parents commonly perceive and report that their child has experienced an AEFI. In this group of parents the subsequent expectation of an AEFI and vaccine safety concerns may be heightened. Further research should investigate parental understandings of differentiating an expected event from an adverse event as this could inform immunization risk communication and consumer AEFI reporting strategies.     

海口市疑似预防接种异常反应监测情况分析

目的:了解疑似预防接种异常反应(AEFI)病例监测运行状况,分析各类疫苗AEFI发生的特点,为改进海口市预防接种疑似预防接种异常反应监测工作提供依据。方法:采用描述流行病学方法对2010年海口市AEFI信息管理系统监测报告个案调查资料进行分析。结果:以区为单位报告发病率均>1/万剂次;48 h及时报告率96.59%,48 h内及时调查率96.15%,个案调查率及完整率100%,3日内调查表报告率54.81%。一类疫苗报告发生率为3.86/万剂次,报告发生率最高的是百白破(8.37/万剂次)。二类疫苗报告发生率为3.28/万剂次,报告发生率最高的为7价肺炎疫苗(20.16/万剂次)。结论:海口市AEFI信息管理系统监测敏感性较高。