Study On The Safety Of EV71 Vaccine For Children Aged 6 Months To 5 Years In Hubei

Objective By analysing the AEFI reporting of inoculating Enterovirus 71(EV71)vaccine for controlling and preventing hand-foot-mouth disease in two cities with high infection rate,Hubei province,this study evaluated the safety of the vaccine applied to children.Methods Though the Childhood Information Management System and the National Surveillance System of Adverse Events Following Immunization(AEFI),immunization information and the case immunizations of 6months to 5 years old children were collected,inoculating EV71 vaccines in community health care centers,hospitals,health-center and center for disease control and prevention of two cities Hubei province during January 2016 to November 2017.Collecting case information of AEFI and immunization information by Excel2007.Descriptive methods and SPSS were used to analyze the information.Results There were 114486 doses EV71 vaccines inoculated in two cities from Jan.1 2016 to Dec.312017.In total,105 AEFI cases were reported(reported rate:0.92 ‰).103 cases as vaccine reaction and 2 cases coincidental illness had been reported.There was no cluster of AEFI.The incidence of adverse reaction of EV71 vaccine(Vero cell)is higher than that of EV71vaccine(human diploid cell)(The general response: χ2=7.977,P=0.005;The abnormal reaction:χ2=4.563,P=0.048).The incidence of vaccine reaction was highest among the group of 6 months to 1 old children(4.21‰),there was lowest in the group of 5 years old.Analysis on vaccine reaction by dose of inoculation,the incidence of first dose(1.15‰)was higher than second dose(0.56 ‰)(χ2=11.080,P=0.001).Analysis on vaccine reaction by interval,the incidence was highest between 30 minute to 1 hour after inoculating vaccine(57%).Analysis on the grade of vaccine reaction by clinical feature,the incidence of general reaction was higher than local reaction.The rate of 2 grade was highest(43.95%).Analysis on vaccine reaction by clinical feather,the rate of common vaccine reaction(89.32%)was higher than rare vaccine reaction(10.68%).The main clinical feature of common vaccine reaction was fever,and the main clinical feature of rare vaccine reaction was anaphylactic rash.Analysis on vaccine reaction by prognosis,all the adverse reactions were cured or improved.No case death or sequela.Conclusions The EV71 vaccine has good post-marketingsafety inoculated in children.The incidence of AEFI was low.The time of adverse reactions after vaccination was mainly within 24 hours after vaccination,and the main clinical manifestations of adverse reactions were fever and abnormal reactions.The adverse reactions turned to recovery or improvement,and no case death or suquelae.In routine vaccination,EV71 vaccine was recommended for children of the right age to prevent HFMD caused by Enterovirus 71.It was recommended to strengthen the observation of adverse reactions 24 hours after vaccination.