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 been crimes committed relating to use of the BCG vaccine. BCG disease outbreak in Finland in the 2000s BCG disease is an adverse effect of the Bacillus Calmette-Guérin vaccine. The vaccine contains living "Mycobacterium bovis" BCG, and in BCG disease, the bacterium causes a disease in persons vaccinated. Between 2000 and 2006, several hundred children in Finland had serious adverse events from the vaccine, including osteitis and osteomyelitis, disseminated (usually fatal) BCG infection, arthritis, and lymph node abscesses. Four deaths were registered in the official adverse event register, and while in only two cases a clear causal link was considered