Abstract
For the next five years, the annual BCG vaccine supply is estimated to be ~2X greater than the annual forecasted demand, which is an increase from the 2017 analysis and is driven by one supplier returning to the market and a new PQ’d vaccine. Regardless of excess global supply, risks remain due to (i) the concentration of a large share of global supply in two suppliers that are regulated by the same NRA, which, coupled with an unstable manufacturing process, can contribute to unexpected and sudden reduction in availability; and (ii) only one product registered in many countries, which could lead to national level stock-outs in the event of production issues. WHO continues to monitor the situation by proactively sharing information, enhancing supply management at country level, communicating the benefits of streamlined regulatory processes, and enhancing collaboration among global partners.