Sanofi Pasteur has announced that it has decided to discontinue production of the BCG vaccine, which is indicated for the treatment and prophylaxis of carcinoma in situ of the urinary bladder.
The hints were there when news trickled of a shortage of the BCG (bacille Calmette-Guerin) live intravesical (TheraCys Intravesical Injection) in September this year. Now, Sanofi Pasteur, the manufacturer of this vaccine—which is indicated for the treatment and prophylaxis of carcinoma in situ of the urinary bladder—has announced that it has decided to discontinue its production.
The news of a drug shortage of the vaccine was announced by the American Society of Health-System Pharmacists a couple of months back. In a letter announcing the decision, Sanofi says that the company did try to restore production to maintain long-term availability of the product, but the efforts fell short. The letter states that production at the drug manufacturing facility in Canada will halt by mid-2017. Anticipating this issue, Sanofi initiated a formal global process to find another company to take up manufacturing and commercialization of BCG, without success.
A problem that the company faced back in 2011 was the presence of mold infections at the manufacturing site, which was called out by the FDA. Merck, the other manufacturer of the vaccine, tried to fill in, but could not keep up with the demand. The next year will bring challenges for both providers and patients diagnosed with bladder cancer.