Analysis of Adverse Events Following Immunization(AEFI) Using The Korea Adverse Event Reporting System(KAERS)

Cha, Hye-gyeong

doi:10.21097/ksw.2016.08.11.3.459

Cited by 2 publications

(6 citation statements)

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“…10 The AEFI studies that have been conducted in South Korea are limited by short study periods, a lack of disproportionality analyses for signal detection, and a lack of information on immunization during pregnancy. 11,12 Thus, our primary objective was to evaluate the overall trends in reported AEFIs over a 13-year period and to detect signals associated with all vaccines that are available in South Korea using traditional data-mining methods to provide safety profiles for these vaccines. As an exploratory objective, we aimed to describe the number of AEFIs reported during pregnancy using the Korea Adverse Event Reporting System (KAERS) database.…”

Section: Updates On Vaccine Safety and Post-licensure Surveillance Fomentioning

confidence: 99%

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

et al. 2020

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Purpose: Vaccine hesitancy is among the top ten threats to global health, and access to precise data on adverse events following immunization (AEFIs) is imperative to alleviate public concerns surrounding vaccines. This study aimed to present the overall trends of AEFIs reported in South Korea. Materials and Methods: We evaluated the trends of AEFIs using the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System database between January 2005 and December 2017. AEFIs were classified into five categories to evaluate associations between vaccines and AEFIs through a case-non-case study: neurologic reactions, general systemic reactions, local reactions, allergic reactions, and others. Results: Among 54378 reported adverse events (AEs) associated with all vaccines approved in South Korea, more than half (56.7%) occurred following influenza vaccination, followed by the pneumococcal (11.6%) and Bacillus Calmette-Guérin (BCG) vaccines (5.0%). After immunization with most vaccines, general systemic reactions were most common, followed by local and neurologic reactions. Adjusted reporting odds ratios were calculated for all neurologic, general, local, and allergic reactions: of all vaccines, rotavirus [neurologic 2.43, 95% confidence interval (CI), 2.25-2.62], BCG (general; 2.20, 95% CI, 1.91-2.53), BCG (local; 3.15, 95% CI, 2.69-3.68), and Japanese encephalitis (allergic 2.38, 95% CI, 1.98-2.87) vaccines showed the highest values. Conclusion: The majority of reported AEFIs were non-serious and mostly general systemic reactions. Sufficient knowledge on the AEFIs would secure public confidence on the safety of vaccines, thereby reducing public health burden from vaccine-preventable diseases.

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Section: Updates On Vaccine Safety and Post-licensure Surveillance Fomentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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“…11 The vaccine injury compensation process is handled by pension offices in each state, and the Research-Based Medicine Regulation (Versorgungsmedizin-Verordnung, VersMedV) is used as the standard framework for determining causality. 12 The appendix to Article 2 of VersMedV addresses aspects related to evaluating causality between a vaccine and an injury that differs from the criteria used for assessing the causality of individual adverse events following immunization. 12 Additionally, the Infection Protection Act (Infektionsschutzgesetz, IfSG) includes separate provisions that outline relaxed criteria for establishing causality between vaccines and vaccine injuries, where demonstrating the probability suffices to deem an injury to be an outcome of vaccination.…”

Section: Current Situation Of Covid-19 Vaccine Injury Compensation Pr...mentioning

confidence: 99%

“… 12 The appendix to Article 2 of VersMedV addresses aspects related to evaluating causality between a vaccine and an injury that differs from the criteria used for assessing the causality of individual adverse events following immunization. 12 Additionally, the Infection Protection Act (Infektionsschutzgesetz, IfSG) includes separate provisions that outline relaxed criteria for establishing causality between vaccines and vaccine injuries, where demonstrating the probability suffices to deem an injury to be an outcome of vaccination. Even when the probability cannot be established, a vaccine injury can be compensated if the decision is supported by the highest authority of the state overseeing the jurisdiction.…”

Section: Current Situation Of Covid-19 Vaccine Injury Compensation Pr...mentioning

confidence: 99%

“…Even when the probability cannot be established, a vaccine injury can be compensated if the decision is supported by the highest authority of the state overseeing the jurisdiction. 12 Between 2009 and 2019, the overall rate of compensation for vaccine injury claims across all 16 German states was approximately 14.3% (306/2,135). Each year, around 200 claims were submitted, with approximately 20–30 approved for compensation.…”

Section: Current Situation Of Covid-19 Vaccine Injury Compensation Pr...mentioning

confidence: 99%

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COVID-19 Vaccine Injury Compensation Program: Lessons Learned From a Review of 10 Implementing Countries

Kang,

Choe,

Yoon

2024

J Korean Med Sci

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National vaccine injury compensation serves as a crucial and significant safety net for individuals affected by government-recommended vaccines during a pandemic, contributing to the community’s overall safety. In the Republic of Korea, compensation for adverse events resulting from coronavirus disease 2019 (COVID-19) vaccinations has been provided through the National Vaccine Injury Compensation Program introduced in 1995. However, there have been limitations with these measures during the COVID-19 pandemic owing to strict criteria for substantiating causality between the vaccine and injury, its nontransparent process of determining whether to compensate, and the compensation amount that is not practically calculated. This article reviewed the Vaccine Injury Compensation Programs in 10 major countries to present implications for improving the Korean system. Expanding the scope of national accountability is essential to compensate for the consequences of adhering to national policies during public health crises. Therefore, valuable insight can be obtained from examining the systems in Germany, Japan, and Taiwan, which have implemented more relaxed criteria for determining causality in compensation cases; Thailand’s system, which provides the mandatory payment of preliminary compensation for damage caused by vaccination; systems in Germany, France, and Japan, which offer compensation for vaccine injuries from a practical perspective; and systems in France and the United Kingdom, which have a process allowing the assessment records to be shared with the claimants. Furthermore, a dedicated agency for vaccine injury compensation, as seen in France, the United Kingdom, and Australia, is necessary to enhance the efficiency of the Korean system.

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Analysis of Adverse Events Following Immunization(AEFI) Using The Korea Adverse Event Reporting System(KAERS)

Cited by 2 publications

References 0 publications

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

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

COVID-19 Vaccine Injury Compensation Program: Lessons Learned From a Review of 10 Implementing Countries

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