Surveillance Of Adverse Reactions Of EV71 Vaccine Vaccination In Hubei Province In 2018

ObjectiveTo monitor and analyze adverse events of EV71 vaccine produced by three manufacturers(represented by A,B and C respectively)used in Hubei Province in2018 by the collection of data from the Adverse Events Following Immunization(AEFI)monitoring system and to further evaluate the safety of EV71 vaccine vaccination in Hubei Province.MethodsThe AEFI cases and the number of vaccination after receiving EV71 vaccine in Hubei province from January 1,2018 to December 31,2018 were collected by the AEFI information management system of China’s immunization planning information management system and Hubei province’s children’s vaccination information management system.Descriptive epidemiological analysis method and geographic information system were adopted to analyze and study the data.ResultsFrom January 1,2018 to December 31,2018,there were 833084 doses of EV71vaccine in Hubei province.And AEFI had 356 cases after EV71 vaccine.The reported incidence rate was 43.73/100,000 doses.Enterprise A,enterprise B and enterprise C reported incidence rates were 43.64/100,000 doses,42.25/100,000 doses and41.78/100,000 doses respectively.Among them,there were 325 cases on general reactions and reported incidence rate was 39.01/100,000 doses.There were 11 cases on abnormal reactions and reported incidence rate was 2.52/100,000 doses.There was 1case on severe adverse reactions and there were 10 cases on coupling disease;There was no psychogenic reaction,vaccine quality accident and vaccination accident.The general reactions were mainly red swelling and induration and the abnormal reaction was mainly allergic skin rash.The reported incidence of EV71 vaccine was relatively high in the central and southern regions of Hubei Province and relatively low in the western and eastern regions.The months with more reported incidence rate of AEFI were concentrated in April to June.The highest reported incidence rate of AEFI was32.29/100,000 doses when the age was between 6 months and 1 year old.The number of reported cases and reported incidence rate decreased with the increase of age.There was significant statistical significance(?~2=276.174,P=0.000).The incidence rate of adverse events after the first dose of EV71 vaccine was higher than that after the second dose(?~2=20.411,P=0.000).Most AEFI occurred when the time was less than or equal to 1 day.Among 356 adverse events,41 cases improved,and they accounted for 11.52%.302 cases recovered and they accounted for 84.83%.11 cases were treated and they accounted for 3.09%.0 cases died and 0 cases were sequelae.ConclusionIn the passive monitoring of adverse events of EV71 vaccines in Hubei Province in 2018,the reported incidence of AEFI of EV71 vaccines produced by three enterprises was all lower.Safety was good and there was no difference.Adverse reactions were mainly general reactions.They were mainly fever,redness and swelling and induration.Abnormal reactions were mainly allergic skin rash.There was no the occurrence of mass AEFI.And there were no AEFI cases with death or disability.Most of the outcomes were recovered or improved.Parents should closely observe children’s reactions within 1 day of vaccination in order to reduce the omission of serious adverse events.Health and disease control departments should strengthen 2 doses of vaccination when they are between 6 months old and 5 years old.In the future,active monitoring combined with passive monitoring should be adopted in order to further improve the sensitivity of monitoring.