Vaccine evaluation studies performed in Korea from 2000 to 2014

Abstract

Purpose: Vaccine evaluation studies were initiated from 2000 by the Ministry of Food and Drug Safety to produce proper data about the safety and immunogenicity of vaccines. The purpose of this study was to review studies and reports on evaluation of vaccine such as immunogenicity, efficacy, effectiveness, safety and other related topics in order to find and analyze the data on the usefulness of each vaccine. Methods: From 2000 to 2014, the project "The vaccine evaluation" had been performed by several researchers, and studies and reports of vaccine evaluation. We reviewed the results and outcomes of studies regarding the evaluation of vaccine’s usefulness and analyzed the possibilities of applying these data for establishing vaccine policies. For each vaccine, data analysis and organization were done according to evaluation fields. Results: A total of 83 studies were performed on vaccines from 2000 to 2014. For each vaccine, 8 studies were performed on BCG, 14 on DTaP/Td, 1 on poliovirus, 5 on Hib, 3 on pneumococcus, 11 on influenza, 3 on hepatitis A, 11 on MMR, 11 on varicella, and 16 on Japanese encephalitis. All studies were analyzed by the following evaluation area, such as safety, immunogenicity, seroprevalence, persistence of immunity, efficacy, effectiveness, vaccine evaluation methods, quality control product for vaccine, and others. Conclusions: Vaccine evaluation studies performed in Korea may be useful as references for establishing vaccination strategy and policy and could be used as baseline data for future studies on vaccine evaluation, vaccine policy establishment, and public/expert vaccine education in Korea. © 2016, Korean Society of Pediatric Infectious Diseases. All rights reserved.