[Recent problem of skin lesions induced by BCG vaccination]

To study the recent trends of occurrence of skin lesions as adverse reactions of vaccination with Bacillus Calmette-Guérin.

The Reports of Vaccination Adverse Reaction Notification by Ministry of Health, Labour & Welfare, and literature retrieved from the Japan Medical Abstract (Centra Medicina Revuo Japana) were reviewed and analysed.

There has recently been an increasing incidence of skin tuberculosis-like lesions as adverse reactions of infants in Japan due to BCG vaccination. According to the reporting system of the adverse reaction of vaccinations, the incidence rate per one million vaccinations was 1.7 from 1995 to 2002 but raised to 11.8 from 2003 to 2005. A similar trend is also seen in case reports in publications. A total of 102 cases were reported in the journals and conferences, out of which 74 were (1) generalized skin rash and 23 were (2) localized skin lesions (the remaining five could not be categorized). Type (1) and type (2) lesions roughly correspond to tuberculids and true skin cutaneous tuberculosis (including wart and lupus), respectively, for skin tuberculosis due to Mycobacterium tuberculosis. The recent increase of these reactions is mostly attributed to the increase in the former type of lesions, which may be associated with the concentration of the BCG vaccination among infants especially after 2005 since when the vaccination has been targeted only at those aged less than 6 months under the new vaccination policy. The prognosis of both lesions is quite good. The antituberculosis treatment was given to only 20% of the former cases and 75% of the latter cases (including surgical procedure), and all were cured or subsided. There were several cases with serious underlying conditions such as severe combined immunodeficiency and Kawasaki disease in the former category.

This type of adverse reaction warrants no serious concern; however, staff members should be able to recognize it adequately so that they can manage it properly and not seriously worry the guardians.