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《Chinese Journal of Vaccines and Immunization》 2007-06
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Study on the Surveillance of Adverse Events Following Immunization in China,2005-2006

LIU Da-wei,GUO Biao,CAO Ling-sheng,et al.(National Immunization Program,Chinese Center for Disease Control and Prevention,Beijing 100050,China)  
Objective This study is to analyze the occurrence features of adverse events following immunization(AEFI)in China,and to evaluate the implementation of AEFI surveillance system,the safety of vaccines related to national immunization program(NIP)and the quality of immunization services.Methods The AEFI data in 2005-2006 were collected through China Information System for NIP Surveillance and reported before June 8,2007.The descriptive methodology is used in this study.Results 4879 AEFI cases occurring in 2005-2006 were reported,of which children ≤1 year accounted for 2/3,the male were more than the female,and the cases more often occurred through May to July each year.NIP vaccines and the first dose of vaccination were significantly related to AEFIs,70% of cases occurred within 2 days after vaccination.The vaccine reactions accounted for 79% among the AEFI classifications.In 10 pilot provinces,the vaccine reaction incidence rate of NIP vaccines is less than the expected.Anaphylaxis,fever and sterile abscess dominated the clinical diagnosis of AEFI cases,with good prognosis for the majority.Sequela or deaths occurred in 1% of cases,mainly contributed to the coincidental illnesses.All AEFI cases came from 5% of provinces and 20% of counties.The number of reported vaccine reactions for NIP vaccines in pilot provinces were much less than the expected,and the reported AEFI incidence rate was low,from 4 to 44 per 1 million doses.The percentage of AEFIs reported within 1 day after identification reached 76%,and the percentage of AEFIs investigated within 1 day after reporting reached 81%.Conclusions Overall,the completeness and sensitivity of national AEFI surveillance system were remarkably low,and the timeliness of surveillance needs to be improved.AEFIs often occur in young children,NIP vaccines,first-dose vaccinations and early periods of vaccinations,which are the focus for the AEFI surveillance.The pilot study shows that the safety of NIP vaccines and the quality of immunization services are satisfactory.
【CateGory Index】: R186
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