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Research Strategies for Assessing Adverse Events Associated withVaccines:: A Workshop Summary
Education of Health Care Providers
A participant noted a problem in persuading doctors and other healthcare providers to report adverse events. Health care providers needto be educated that VAERS is an adverse “event” reporting system, not anadverse “effect” reporting system. That is, physicians or other health careproviders sometimes fail to report an event after vaccination becausethey do not believe that the event is related to vaccination. Thistacit decision to report only well-established adverse consequencesof vaccines means that the previously unrecognized effects of vaccineswould continue to go unnoticed. If a passive surveillance systemis to function effectively as a signal detection system, then allserious adverse events that occur following vaccination should bereported.
A participant noted that, with the advent of the new presidentialadministration, immunization policy in general is being reevaluated.The education of practitioners, including information about adverseevents and the provision of instructions on how to report them, isexpected to be an integral part of a new immunization program.
Vaccine Injury Compensation Program
A participant noted that the Vaccine Injury Compensation Program(VICP) also serves as a passive reporting system that might supplementthe information in VAERS. There is potentially more useful informationin the records from VICP than in those from VAERS, because vaccineesor their parents are required to submit complete medical informationto be considered for compensation. In addition, there could be casesin the VICP that are not in VAERS. For example, the participant noteda case submitted to VICP (but not to VAERS) of two episodes of Guillain-Barré syndrome (GBS) in the same child after administration of a tetanustoxoid-containing preparation. The possibility of linking the VAERSand VICP databases is under active discussion within PHS. Anotherparticipant noted that databases from Japan might be informative,for example, for providing information on that country's experienceswhen it changed from recommending DPT vaccination in infancy to age2 years and older.
Evaluation of Passive Surveillance Systems
An evaluation of VAERS itself and how it has functioned thus farwas suggested. It should be determined, for example, whether VAERSactually has served well as the signal detector that a passive surveillancesystem is intended to be. Research to compare surveillance systemswas suggested—to find out, for example, what proportion of casesof various sorts are reported to VAERS. This