摘要：This report summarises Australian passive surveillance data on adverse events following immunisation (AEFI) for 2004 and describes reporting trends over the fi ve years, 2000 to 2004. AEFIs are notifi ed to the Adverse Drug Reactions Advisory Committee by state and territory health departments, hospi-tals, 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 popula-tion, 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 in. uenza vaccine for adults aged ≥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 defi ned 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 fi fth 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.
关键词：AEFI; adverse events; vaccines; surveillance; immunisation; vaccine safety;1. National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases; University of Sydney and ;The Children's Hospital at Westmead; Sydney; New South Wales;2. Adverse Drug Reactions Unit; Therapeutic Goods Administration; Canberra; Australian Capital Territory;3. Adverse Drug Reactions Advisory Committee and the Children's Hospital at Westmead; Westmead; New South Wales;Corresponding author: Dr Glenda Lawrence; National Centre for Immunisation Research and Surveillance of Vaccine Preventable ;Diseases; Locked Bag 4001; Westmead NSW 2145. Telephone: +61 2 9845 1433. Facsimile: +61 2 9845 1418. ;Email: glendal@chw.edu.au;Introduction;Ongoing surveillance of adverse events following ;immunisation (AEFI); and regular analysis and report-;ing of these data; are integral to the management of ;immunisation programs. The aim of AEFI surveillance ;is to monitor vaccine and immunisation program safety ;and to detect population-specifi c; rare; late-onset or ;unexpected adverse events that may not be detected ;in pre-licensure vaccine trials.;1–3;An 'adverse event ;following immunisation' is defi ned as any serious or ;unexpected adverse event that occurs after a vac-;cination has been given which may be related to the ;vaccine itself or to its handling or administration.;1;An ;AEFI can be coincidentally associated with the timing ;of immunisation without necessarily being caused by ;the vaccine or the immunisation process.;In Australia; AEFIs are notifi ed to the Adverse Drug ;Reactions Advisory Committee (ADRAC) by state ;and territory health departments; health care profes-;sionals; vaccine manufacturers and members of the ;public.;4;5;All reports received by ADRAC are evalu-;ated using internationally consistent criteria;6;and are ;reviewed at regular meetings. These passive AEFI ;surveillance data have been collated in the ADRAC ;database since 2000 and are used to monitor trends; ;detect signals and generate hypotheses. Reports ;summarising national AEFI surveillance data have ;been published regularly since 2003.;7–9;This report ;summarises AEFI data reported to ADRAC for ;vaccines received during 2004 and trends in AEFI ;reporting for the fi ve year period 2000–2004.; var currentpos;timer; function initialize() { timer=setInterval("scrollwindow()";10);} function sc(){clearInterval(timer); }function scrollwindow() { currentpos=document.body.scrollTop; window.scroll(0;++currentpos); if (currentpos != document.body.scrollTop) sc();} document.onmousedown=scdocument.ondblclick=initializeCDI Vol 29 No 3 2005 ;249;Surveillance of adverse events following immunisation; 2004 ;Annual report;Several important changes both to AEFI surveillance ;methods and to the Australian childhood vaccination ;schedule occurred during 2003 and 2004 that affect ;the AEFI surveillance data presented in this report. ;In September 2003; the 8th edition of the Australian ;Immunisation Handbook;5;was released. The case ;defi nitions of several AEFIs; including those for ;anaphylactic reaction and allergic reaction; differed ;from those shown in the 7th edition of the Australian ;Immunisation Handbook.;4;Coinciding with the ;release of the 8th edition of the Handbook were a ;number of changes to the immunisation schedule; ;including the removal of the 4th dose of DTPa (due ;at 18 months of age) and new recommendations ;that all children receive three vaccines not included ;in the funded National Immunisation Program at the ;time (i.e. 7-valent pneumococcal conjugate vaccine ;(7vPCV); varicella vaccine and inactivated poliomy-;elitis vaccine).;5;Also the meningococcal C conjugate ;vaccine catch-up immunisation program for those ;aged 1–19 years; which commenced in 2003; was ;completed for most school-aged and pre-school ;children during 2004.;10;Methods;Adverse events following immunisation data;De-identifi ed information was released to the ;Nat ;ional Centre for Immunisation Research and ;Surveill ;ance for all drug and vaccine adverse event ;notifi cations received by ADRAC between 1 January ;2000 and 31 March 2005. Readers are referred to ;previous AEFI surveillance reports for a description ;of the AEFI surveillance system and methods used ;to evaluate AEFI reports received by ADRAC.;7;8;ADRAC database records;*;were eligible for inclusion ;in the analysis if:;. a vaccine was recorded as 'suspected' of involve-;ment in the reported adverse event and;. either (a) the vaccination occurred between 1 Jan-;uary 2000 and 31 December 2004 or (b) if no vac-;cination date was recorded; the date of onset of ;symptoms or signs occurred between 1 January ;2000 and 31 December 2004.;* The term 'AEFI record' is used throughout this report because ;a single AEFI notifi cation to ADRAC can generate more ;than one record in the database. For example if a notifi ca-;tion describes an injection site reaction plus symptoms and ;signs of a systemic adverse event (e.g. fever or generalised ;allergic reaction); two records will appear in the database: ;one record containing information relevant to the injection ;site reaction and one record for the systemic adverse event.;Study defi nitions of adverse events following ;immunisation outcomes and reactions;AEFIs were defi ned as 'serious' or 'non-serious' ;based on information recorded in the ADRAC data-;base and criteria similar to those used by the World ;Health Organization;6;and the US Vaccine Adverse ;Events Reporting System (VAERS).;11;In this report; ;an AEFI is defi ned as 'serious' if the record indicated ;the person had recovered with sequelae; been ;admitted to hospital; experienced a life-threatening ;event; or died.;Typically; each AEFI record listed several symptoms; ;signs and diagnoses that had been re-coded from ;the reporter's description into standardised terms ;using the Medical Dictionary for Regulatory Activities ;(MedDRA;.;).;12 ;To simplify data analysis; we grouped ;MedDRA;.;coding terms to create a set of reaction ;categories. Firstly; reaction categories were created ;that were analogous to the AEFIs listed and defi ned ;in the Australian Immunisation Handbook (8th edi-;tion).;5;The category created for 'allergic reaction' for ;this report differs from previous reports to re. ect the ;change in the defi nition of 'allergic reaction (gener-;alised)' in the 8th edition of the Handbook; where ;both skin and gastrointestinal symptoms and signs ;are included.;5;A new category was created; 'severe ;allergic reaction'; to capture reports of a generalised ;allergic reaction that involved symptoms and signs ;of the circulatory and/or respiratory system but had ;not been coded in the dataset as 'anaphylactic reac-;tion'. Reaction categories were not created for two ;new AEFIs listed in the 8th edition of the Handbook ;('extensive limb swelling' and 'nodule') due to the lack ;of specifi c MedDRA;. ;coding terms for these AEFIs. ;Instead; these AEFIs are included in the category of ;'injection site reaction'. A separate reaction category ;was created where symptoms and signs describing ;a hypotonic-hyporesponsive episode (HHE) or HHE-;like event were mentioned but the specifi c terms of ;HHE was not present. This defi nition was based on ;the Brighton Collaboration case defi nition for HHE ;(level 2 of diagnostic certainty).;13 ;A 'possible HHE' ;in this report is defi ned as hypotonia plus terms ;describing colour change (pallor; cyanosis) and/or ;hyporesponsiveness (somnolence; hypokinesia); in ;the absence of terms related to other AEFIs such as ;convulsion.;Additional categories were created for MedDRA;. ;coding terms that were listed in more than one per ;cent of AEFI records (e.g. headache; irritability; ;cough). Reaction terms listed in less than one per ;cent of records were grouped into broader catego-;ries based on the organ system where the reaction ;was manifested (e.g. gastrointestinal; neurological).
