Clin Exp Vaccine Res.  2020 Jul;9(2):133-145. 10.7774/cevr.2020.9.2.133.

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

Affiliations
  • 1Department of Pediatrics, Chungnam National University College of Medicine, Daejeon, Korea.
  • 2Division of Vaccine-Preventable Disease Control and National Immunization Program, Korea, Centers for Disease Control and Prevention, Cheongju, Korea.
  • 3Department of Preventive Medicine, Chungnam National University College of Medicine, Daejeon, Korea.
  • 4Department of Pediatrics, Incheon Medical Center, Incheon, Korea.

Abstract

Purpose
The report of adverse events following immunization (AEFI) in Korea has continued since 1994, and the most frequently reported cases of AEFI of Korea Centers for Disease Control and Prevention (KCDC) is bacille Calmette-Guérin (BCG). Meanwhile, various inoculation methods and strains have been used in the past 6 years in Korea. Therefore, we investigated AEFI of BCG by strain types and inoculation methods using immunization safety surveillance of KCDC.
Materials and Methods
We reviewed BCG AEFIs registered in the KCDC from January 2013 to June 2018.
Results
There were 336 AEFI cases during the period, and average time interval from vaccination to symptom onset was within 2 months. AEFI proportion was 6.4 cases per 100,000 doses for BCG percutaneous Tokyo strain, 41.6 cases per 100,000 doses of BCG intradermal Danish strain, and 25.9 cases per 100,000 doses of BCG intradermal Tokyo strain. Intradermal type was more reported AEFI than percutaneous type in the same strain. The most common adverse events were local reaction like BCG lymphadenitis and severe adverse reactions such as osteomyelitis or disseminated BCG disease were 0.1 to 0.2 cases per 100,000 doses which are correlated with the range of World Health Organization published AEFI rates.
Conclusion
The AEFI reporting rate does not equal the actual proportion of AEFI occurrence. Because AEFI monitoring is a passive surveillance system, various factors might influence the number of events reported. Nevertheless, it is important to analyze BCG AEFI by vaccine strains and inoculation method using surveillance data of KCDC.

Keyword

BCG vaccine; Adverse event following immunization; Surveillance
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