Epidemiological Methods for Pharmaco-Vigilance: The Case of Vaccine Safety

Abstract

Pharmacovigilance is "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem". There is criticism that drug safety reporting in medical research is inadequate. There is possibility of many types of bias in vaccine safety studies especially in the diagnostic process, at investigator level and in the process of recall. Vaccines generally have two primary concerns. Clinical research is the method for establishing both. Epidemiology is the methodology for research and is the foundation for evidence based vaccine delivery in the community in the clinical practice mode as well as immunization program mode.