Surveillance of suspected adverse event following immunization with Bacillus Calmette-Guérin vaccine in Jiangsu Province from 2018 to 2022
Objective To investigate the epidemiological characteristics of suspected adverse event following immunization(AEFI)with Bacillus Calmette-Guérin(BCG)vaccine in Jiangsu Province and to evaluate the safety of BCG vaccination.Methods Individual data of AEFI with BCG vaccines and BCG vaccination data were collected from China Information System for Disease Control and Pre-vention and Jiangsu Province Vaccination Integrated Service Management Information System from 2018 to 2022,and AEFI was ana-lyzed with a descriptive epidemiological method.Results A total of 544 individual cases with AEFI caused by BCG vaccination were reported in Jiangsu Province from 2018 to 2022,and the reported incidence of AEFI reduced from 53.86/105 doses in 2018 to 12.42/105 doses in 2022,with annual mean incidence of 27.18/105 doses and appearing a tendency towards a decline over years from 2018 to 2022(x2=126.44,P＜0.01).The numbers of general,abnormal and coincidental reactions were 271(13.54/105 doses incidence),258(12.89/105 doses incidence)cases and 15 cases(0.75/105 doses incidence).Local abscess(5.84/105 doses)and BCG lymphadenitis(4.00/105 doses)were the two most common abnormal reactions,and the reported incidence of systemic disseminated BCG infections was 0.15/105 doses.Conclusions The reported incidence of AEFI with BCG vaccines appeared a tendency towards a decline in Jiangsu Province over years from 2018 to 2022,and local abscess was the predominant abnormal reaction,with rare serious adverse events seen.The safety of BCG vaccines is within the expected limit.
Bacillus Calmette-Guérin vaccineSuspected adverse event following immunizationSurveillanceEpidemiological char-acteristic
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