BCG vaccine extensively used even in countries where efficacy against pulmonary tuberculosis is negligible. A number of possible reasons for the variable efficacy of BCG in different countries have been proposed. None have been proven, some have been disproved, and none can explain the lack of efficacy in both low-TB burden countries (US) and high-TB burden countries (India). The reasons for variable efficacy have been discussed at length in a WHO document on BCG. BCG has protective effects against some non-tuberculosis mycobacteria. BCG has been one of the most successful immunotherapies. BCG vaccine has been the "standard of care for patients with
BCG disease outbreak in Finland in the 2000s to a different strain. In August 2002, the BCG vaccine used in Finland was discontinued by the manufacturer after factory inspectors were dissatisfied with the manufacturing process. Finland switched to a Danish strain BCG vaccine which did not have marketing authorization in Finland. Despite lack of marketing authorization, the vaccine was offered and recommended to all Finnish newborns (ca. 55 000 - 60 000 per year), and parents were not told the vaccine had no marketing authorization as required by Finnish and European Union legislation. The vaccine was injected into the thigh of newborns, despite clear manufacturer instructions that the