Surveillance and compensation claims for adverse events following immunization from 2011 to 2016 in the Republic of Korea

Abstract

PurposeIn recent years, research on reported adverse events following immunization (AEFI) and claims filed for compensation has been lacking. We reviewed reported AEFIs and compensation claims in Korea from 2011 to 2016.Materials and MethodsWe listed all of the AEFI registered in the Integrated Management System of Disease and Public Health and reviewed the list of claims filed and serious AEFIs reported from 2011 to 2016.ResultsAn average of 278 AEFI cases was reported annually from 2011 to 2016. Of these, 31 deaths were reported. However, there was no association found between these deaths and vaccinations when evaluating vaccine lot, reviewing autopsies, and considering underlying diseases. AEFI reporting rate was as high as 20.8 cases for bacillus Calmette–Guérin (BCG) vaccine, 7.3 cases for 23-valent pneumococcal polysaccharide vaccine (PPV23), and 5.4 cases for human papillomavirus vaccine per 100,000 vaccination doses in 2016. Of the 469 total cases that claimed vaccine injury compensation from 2011 to 2016, the BCG vaccine was most commonly involved, with 235 cases (50%), followed by influenza vaccine and PPV23, with 90 and 55 cases, respectively. Of these cases, 96% of BCG-related AEFI were compensated, while only 31% and 49% of AEFI following influenza and PPV23 vaccination, respectively, were compensated. Common characteristics of uncompensated cases included the elderly subjects, receiving influenza vaccine, having underlying disease, or a very short time interval between vaccination and symptoms.ConclusionWe have maintained vaccine safety management system through both rapid response to serious AEFI and vaccine injury compensation in order to sustain public trust in the National Immunization Program.

Vaccination in everyday life: experiences indicate Permanent Education

“…34 A study conducted in the Republic of Korea has identified an annual average of 278 cases of AEFI. 35 These data corroborate the responsibility of the professionals who deal daily with the administration of the immunobiological agents, since errors of conservation, handling and application of the immunobiological can result in AEFI.…”

Updates on Vaccine Safety and Post-Licensure Surveillance for Adverse Events Following Immunization in South Korea, 2005–2017

“…20 Additionally, the South Korean government operates a routine compensation system for AEs and has been providing compensation for 95% of the claims regarding BCG. 21,22 In our study, the Japanese encephalitis vaccine showed an association with allergic reactions, most of which were hypersensitivity reactions and urticaria. Allergic reactions to the Japanese encephalitis vaccine, including urticaria, anaphylaxis, and angioedema, have been reported in several studies.…”

“… 20 Additionally, the South Korean government operates a routine compensation system for AEs and has been providing compensation for 95% of the claims regarding BCG. 21 22 …”

Investigation of adverse events following bacille Calmette-Guérin immunization using immunization safety surveillance system in Korea Centers for Disease Control and Prevention

“…The report of AEFI in Korea has continued since 1994 and it has been dualized to the Korea Institute of Drug Safety and the KCDC to monitor the adverse events (2012) [ 7 ]. The most frequently reported cases of AEFI of KCDC is BCG, which is more than 20% of all reported cases each year [ 8 ]. Very few previous studies have reviewed the reported adverse event after BCG vaccination.…”