Bacillus Calmette-Guérin (BCG) availability is a significant concern for patients and healthcare providers globally. This treatment, used for certain cancers, faces ongoing supply challenges. Understanding the shortage and its implications is important for those navigating treatment options.
What is BCG
Bacillus Calmette-Guérin (BCG) is an immunotherapy derived from a live, attenuated strain of Mycobacterium bovis, a bacterium related to the one that causes tuberculosis. While initially developed as a tuberculosis vaccine, its primary medical application today is in the treatment of non-muscle invasive bladder cancer (NMIBC). When administered directly into the bladder through a catheter, BCG stimulates the body’s immune system to target and destroy cancer cells.
BCG is the standard treatment for high-risk NMIBC following surgical removal of the tumor, aiming to prevent recurrence and progression of the disease. The initial treatment typically involves a six-week course, often followed by maintenance therapy that can last for one to three years to reduce the risk of the cancer returning. Unlike chemotherapy, which directly kills cancer cells, BCG works by activating an immune response within the bladder.
Current Status of the BCG Shortage
A persistent global shortage of BCG has impacted bladder cancer treatment for over a decade. The shortage became prominent in 2014, when Merck, a major manufacturer, announced supply constraints for its TICE strain of BCG. Sanofi Pasteur eventually discontinued production of its BCG product in 2016, citing manufacturing challenges, leaving Merck as the sole supplier in many countries, including the United States.
The underlying reasons for the ongoing shortage are multifaceted, involving complex manufacturing processes, reliance on a limited number of producers, and increasing global demand. Producing BCG is a lengthy process, with each batch taking over three months to make, including a month for bacterial growth. Despite Merck increasing production capacity by over 100% since 2012 and operating at maximum capacity, global demand has continued to outpace supply.
Consequences for Patient Care
The prolonged BCG shortage has affected patients with non-muscle invasive bladder cancer, altering treatment protocols and creating anxieties. Patients face delayed or interrupted treatments and dose reductions due to limited availability. Healthcare providers consider alternative therapies when BCG is unavailable, which may not offer the same efficacy for high-risk disease.
This suboptimal treatment can increase disease recurrence or progression risk for some patients. The shortage places an emotional burden on patients, who worry about alternative treatment effectiveness or cancer worsening. Healthcare providers also face challenges managing patient care amidst supply constraints, needing to prioritize BCG for the highest-risk cases.
Efforts to Resolve the Shortage
Various stakeholders are working to address the persistent BCG shortage. Merck announced plans in October 2020 to construct a new manufacturing facility in North Carolina, aiming to triple its current BCG production capacity. This facility is expected to be operational by late 2026, following regulatory review, and is anticipated to meet future demand.
Regulatory bodies, like the FDA, are also expanding supply. In February 2025, the FDA authorized an expanded access program to introduce recombinant BCG (rBCG) from the Serum Institute of India (SII) as an alternative source for U.S. patients. This rBCG has shown promising immunogenicity and an improved safety profile in European clinical trials. The shortage has also spurred research into alternative intravesical therapies, with new agents and optimized dosing regimens explored in clinical trials to provide more patient options.