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.
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.
ABSTRACT
Background@#A national immunization program (NIP) to prevent disease and reduce mortality from vaccine preventable diseases (VPD) is very important. @*Methods@#We analyzed only the anaphylaxis cases that occurred between 2001 and 2016 that Korea Centers for Disease Control and Prevention (KCDC) determined had a definite causal relationship with a vaccine. The clinical symptoms were assessed according to the Brighton Collaboration case definition (BCCD) level. @*Results@#During the period, there were 13 cases of vaccine-related anaphylaxis. The median age was 9 years (range, 1 month to 59 years). The incidence of anaphylaxis per million doses was 0.090 in 2005, 0.079 in 2012, 0.071 in 2013, 0.188 in 2015, and 0.036 in 2016. Of those cases, 23.1% were influenza vaccines, and 76.9% were BCCD level 2. Epinephrine was used in 46.2%. @*Conclusion@#Vaccine-related anaphylaxis seems to have been very rare in the past, but health care professionals must always be aware of anaphylaxis.