BCG vaccine produce BCG. Along with supply availability from existing manufacturers, and a "new WHO prequalified vaccine" the total supply will be "sufficient to meet both suppressed 2015 demand carried over to 2016, as well as total forecast demand through 2016-2018." In the fall of 2011, the Sanofi Pasteur plant flooded causing problems with mold. The facility, located in Toronto, Ontario, Canada, produced BCG vaccine products, made with substrain Connaught, such as a tuberculosis vaccine ImmuCYST, a BCG Immunotherapeutic – a bladder cancer drug. By April 2012 the FDA had found dozens of documented problems with sterility at the plant including mold,
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