Adverse Events Induced by BCG Immunization in Taiwan

Gwo-Chang Sheu

2008 Vol.24 NO.5

Correspondence Author: Gwo-Chang Sheu


The Pasteur strain 1173 P2 was originally used for Bacillus Calmette-Guerin (BCG) vaccine production in Taiwan and was substituted by the Tokyo strain 172 in 1979. The lymphadenopathy investigation proceeded from 1969 to 1982 revealed that the side effect of lymphadenopathy caused by Tokyo 172 was lower than Pasteur strain 1173 P2. From 1998 to 2007, there were 14 cases applied for compensation on BCG-caused adverse reaction, and six of them were confirmed after investigation. BCG vaccination caused five cases of humeral or sternal osteomyelitis and one death resulting from disseminated BCG infection. Between 2002 and 2006, the incidence of BCG osteomyelitis was 3.68 cases per million doses and the incidence of disseminated BCG infection was 0.9 case per million doses. In order to understand the real situation of adverse reaction caused by BCG vaccination, to establish the BCG safety profile, and to improve the BCG production in Taiwan, long-term systematic investigations of adverse reactions caused by BCG vaccination is recommended.
Key words: suppurative lymphadenitis, BCG osteitis/osteomyelitis, disseminated BCG infection.