Clin Exp Vaccine Res.  2017 Jul;6(2):146-155. 10.7774/cevr.2017.6.2.146.

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

• Kim MK
• Lee YK
• Kim TE
• Kong I
• Yang HJ
• Suh ES

• KMID: 2391575
• DOI: http://doi.org/10.7774/cevr.2017.6.2.146

Abstract

PURPOSE
In 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 METHODS
We 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.
RESULTS
An 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.
CONCLUSION
We 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.

Keyword

Vaccination; Drug-related side effects and adverse reactions; Public health surveillance; Compensation and redress; Government programs

MeSH Terms

Aged
Autopsy
Bacillus
BCG Vaccine
Compensation and Redress*
Drug-Related Side Effects and Adverse Reactions
Government Programs
Humans
Immunization Programs
Immunization*
Influenza Vaccines
Influenza, Human
Korea
Pneumococcal Vaccines
Public Health
Public Health Surveillance
Republic of Korea*
Safety Management
Vaccination
BCG Vaccine
Influenza Vaccines
Pneumococcal Vaccines

Reference

1. Williams SE, Klein NP, Halsey N, et al. Overview of the clinical consult case review of adverse events following immunization: Clinical Immunization Safety Assessment (CISA) network 2004-2009. Vaccine. 2011; 29:6920–6927. PMID: 21801776.

2. Gangarosa EJ, Galazka AM, Wolfe CR, et al. Impact of anti-vaccine movements on pertussis control: the untold story. Lancet. 1998; 351:356–361. PMID: 9652634.

3. Krantz I, Taranger J, Trollfors B. Estimating incidence of whooping cough over time: a cross-sectional recall study of four Swedish birth cohorts. Int J Epidemiol. 1989; 18:959–963. PMID: 2621033.

4. Miller DL, Alderslade R, Ross EM. Whooping cough and whooping cough vaccine: the risks and benefits debate. Epidemiol Rev. 1982; 4:1–24. PMID: 6128242.

5. Lee JK, Choi WS. Immunization policy in Korea. Infect Chemother. 2008; 40:14–23.

6. Lee HJ, Sohn YM, Kim JS, Kim YT, Lee JG, Choi BY. Analysis of the adverse events following immunization of the national compensation program and the surveillance system in Korea, 1995-2000. Pediatr Infect Vaccine. 2001; 8:135–149.

7. Choe YJ, Bae GR. Management of vaccine safety in Korea. Clin Exp Vaccine Res. 2013; 2:40–45. PMID: 23596589.

8. Korea Centers for Disease Control & Prevention. Guidelines for the adverse event following immunization management. Cheongju: Korea Centers for Disease Control & Prevention;2014.

9. Collet JP, MacDonald N, Cashman N, Pless R. Monitoring signals for vaccine safety: the assessment of individual adverse event reports by an expert advisory committee. Advisory Committee on Causality Assessment. Bull World Health Organ. 2000; 78:178–185. PMID: 10743282.

10. Tozzi AE, Asturias EJ, Balakrishnan MR, Halsey NA, Law B, Zuber PL. Assessment of causality of individual adverse events following immunization (AEFI): a WHO tool for global use. Vaccine. 2013; 31:5041–5046. PMID: 24021304.

11. Halabi SF, Omer SB. A global vaccine injury compensation system. JAMA. 2017; 317:471–472. PMID: 28114657.

12. Kim JH, Cho HY, Hennessey KA, Lee HJ, Bae GR, Kim HC. Adverse events following immunization (AEFI) with the novel influenza a (H1N1) 2009 vaccine: findings from the national registry of all vaccine recipients and AEFI and the passive surveillance system in South Korea. Jpn J Infect Dis. 2012; 65:99–104. PMID: 22446114.

13. Hanley SJ, Yoshioka E, Ito Y, Kishi R. HPV vaccination crisis in Japan. Lancet. 2015; 385:2571. PMID: 26122153.

14. Larson HJ, Wilson R, Hanley S, Parys A, Paterson P. Tracking the global spread of vaccine sentiments: the global response to Japan’s suspension of its HPV vaccine recommendation. Hum Vaccin Immunother. 2014; 10:2543–2550. PMID: 25483472.

15. Miller ER, Harber P, Hibbs B, Broder K. Chapter 21. Surveillance for adverse events following immunization using the vaccine adverse event reporting system (VAERS). Centers for Disease Control and Prevention. VPD surveillance manual. 5th ed. Atlanta, GA: Centers for Disease Control and Prevention;2011. p. 1–14.

16. Singleton JA, Lloyd JC, Mootrey GT, Salive ME, Chen RT. An overview of the vaccine adverse event reporting system (VAERS) as a surveillance system. VAERS Working Group. Vaccine. 1999; 17:2908–2917. PMID: 10438063.

17. von Elten KA, Duran LL, Banks TA, Banks TA, Collins LC, Collins LC. Systemic inflammatory reaction after pneumococcal vaccine: a case series. Hum Vaccin Immunother. 2014; 10:1767–1770. PMID: 24642659.