safety surveillance for smallpox vaccine建立安全监测的天花疫苗（ppt42）课件

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1、EstablishingSafetySurveillanceforSmallpoxVaccineObjectivesforSafetyMonitoringDetectprogramerrorsCorrelatewithspecificlotorbrandIdentifynon-correlatedeventsMaintainconfidenceinimmunizationprogramsGeneratenewhypothesesComparerateswithknowndataGeneralStepstoEstab

2、lishingVaccineSafetySurveillanceStepstoEstablishingaSystemRolesofRegulatoryandEpiIdentifyresourcesavailableAppointordesignateassessorsEstablishexpertcommitteeDistributelistofeventstobereportedTrainstaffatalllevelsInformhealthcareworkersofneedtoreportConsiderco

3、mpensationschemeWhattoReport?SeriousadverseeventsCertainmoderateeventsSee“ImmunizationSafetySurveillance”guidelinesfromWHOCurrentGeneralVaccineSafetyInfrastructureUSAVaccineSafetyMonitoringKeyComponentsVAERSHypothesisGenerationCouldVaccineCauseAE?VSDHypothesis

4、TestingDidVaccineCauseAE?RISKCOMMUNICATIONSDisseminatingResultsVACCINEDEVELOPMENTEnsuresaferVaccinationIOMHypothesisEvaluationLevelofPHConcern?CISAHypothesisClarificationClinicalSyndromes?HEALTHCAREDiagnoseandManageCausedbyVaccine?TheVaccineAdverseEventReporti

5、ngSystemWhatisVAERS?NationalpassivesurveillancesystemformedicaleventstemporallyassociatedwithU.S.licensedvaccinesCo-managedbyCDCandFDAEstablishedin1990CertainreportingmandatedbylawDeliverypointforsmallpoxadverseeventreportsVAERSReportingFormVAERSReportingFormD

6、ateofbirth,age,sexDescriptionofadverseeventOutcome(recoverystatus)DateofvaccinationAdverseeventonsetAllvaccinesadministeredSourceofreport,vaccinepurchase/adminPre-existingillness,medicationsRelevantdiagnostictests/labdataVAERSRoleinSmallpoxVaccineResponseSingl

7、elocusforreportingVaccineAdverseEvents(VAEs):NationalinscopeKnowntohealthcareprovidersElectronicreportingasofJanuary1,2002EstablishedmechanismsandtrainedstaffforenhancedfollowupofseriousreportsBUTVAERS:NotabletodeterminecausalityDoesnotprovideclinicalcaseinves

8、tigationInstituteofMedicineReviewVAERSdataPublichealthsignificance?ReviewhypothesesClinicalImmunizationSafetyAssessment(CISA)NetworkAcademiccentersofexcellence(4)inpartnershipwithC