Safety Surveillance for Smallpox Vaccine建立安全监测的天花疫苗.ppt

Establishing Safety Surveillance for Smallpox Vaccine ;Objectives for Safety Monitoring;General Steps to Establishing Vaccine Safety Surveillance;Steps to Establishing a System;What to Report?;Current General Vaccine Safety Infrastructure USA;Vaccine Safety MonitoringKey Components;The Vaccine Adverse Event Reporting SystemWhat is VAERS?;VAERS Reporting Form;VAERS Reporting Form;VAERS Role in Smallpox Vaccine Response;Institute of Medicine;Clinical Immunization Safety Assessment (CISA) Network;Overall Goals relating to VAEs: Develop clinical evaluation and management protocols Improve understanding of VAEs’ pathophysiology at the individual patient level Identify genetic or risk factors for predisposed groups Provide expert advice for supervised immunization and clarify valid contraindications for reimmunization in high-risk groups Serve as regional referral center for safety inquires Conduct formal causality assessment and case review;Vaccine Safety Datalink;Why Monitor Smallpox Vaccine Safety?;Smallpox Vaccine AE Monitoring Needs;Pre-Outbreak Smallpox Vaccine AE Monitoring ;Safety Steps at Time of Vaccination;Recognition of a Problem Individual;Response to a Problem Individual;Recognition of a Problem PopulationPopulation: unusual reactions or high rates;Identify groups at risk for VAE: ? New contraindications ? Screening for contraindications not consistent. ? Unavoidable VAEs (e.g., person with contraindication was also high-risk contact in post-outbreak setting) Determine if VAEs differ by lot, clinic, etc. Determine if AE resulted from treatment of vaccine reaction (e.g., renal failure from Cidofovir) Investigate pathophysiology of VAE Develop new, safer vaccine;Smallpox Vaccine Safety WorkgroupAdvisory Committee on Immunization Practices;Post-Outbreak Smallpox Vaccine AE Monitoring;Smallpox Vaccine Safety System;Basic Overview of Smallpox Vaccine Adverse Events Reporting;Reporting Adverse Events Following Smallpox Vaccine;Smallpox Adverse Events to