Improving global monitoring of vaccine safety: An evaluation of the World Health Organization Programme for International Drug Monitoring and Adverse Reactions Database on how they serve the needs of vaccine safety

Abstract

The World Health Organization (WHO) Programme for International Drug Monitoring (PIDM) was developed for chemical rather than biological products. The ability of the PIDM to meet the needs of vaccine safety is of international public health importance. Three studies were conducted: (1) a survey of authorities responsible for reporting adverse events following immunizations (AEFIs); (2) an analysis of the WHO Adverse Reactions Database; and (3) a systematic review to identify and compare Bayesian methods used in drug and vaccine signaling. Communication between national surveillance authorities and lack of vaccine-specific terminologies are issues of concern. Many AEFI reports are not forwarded to the PIDM, and reporting timeliness and regularity should be improved. Few studies have examined the use of Bayesian methods in vaccine signaling. Vaccines should be recognized as a distinct group of drugs. Additional staff dedicated to AEFI reporting and vaccine signaling would be a valuable asset to the PIDM.