An ongoing contamination problem at Sanofi Pasteur’s Toronto facility may affect global supplies of the bladder cancer drug ImmuCyst, Health Canada said Wednesday, reporting that it uncovered mold in what should have been a completely sterile manufacturing area in the same building ImmuCyst is produced.
A spokesperson said Sanofi has decided to pause production and repair the building – work that will begin shortly. The Toronto plant is the only one within the Sanofi network that makes ImmuCyst.
The apparent root of the problem is a flood from last October, which was also to blame for taking out Canada’s only source of the tuberculosis vaccine.”We don’t anticipate BCG back on the market until the end of 2013,” Nancy Simpson said in an email.
BCG stands for Bacille Calmette-Guerin, a live but weakened strain of Mycobacterium bovis, the bacterium that causes tuberculosis in cows. It’s related to the bacterium that causes TB in people and is used in the production of tuberculosis vaccine. (BCG is named after Albert Calmette and Camille Guerin who developed the live-bacteria strain in the early 1900s). Additionally, you might know the bacterium as the therapy for bladder cancer.
Last month, Health Canada announced that Sanofi was recalling all existing vials of its tuberculosis vaccine because of concerns it might have been contaminated in the production process.
Sanofi’s BCG vaccine is the only one that’s licensed for use in the country at this point in time, so authorities started then to search for an alternative. Their search has not yet borne fruit.
The Public Health Agency of Canada is spearheading a mission to find an alternative source of the vaccine. The Agency reported on Wednesday that both themselves and Health Canada are utilizing all their resources in order to come up with a solution – a safe alternative.
Health Canada said it would permit the distribution of the bladder cancer drug, following Sanofi’s TB vaccine, even though it was produced in the affected building. On Wednesday, the agency said it was still willing to allow the company to release supplies of ImmuCyst, though it said each lot would have to undergo safety testing before being shipped.
“After conducting a health risk assessment, Health Canada believes that the benefits of the ImmuCyst (bladder cancer) product continue to outweigh any risks,” the department said in their response to questions, via email, adding too that “undistributed lots of ImmuCyst will be made available in Canada if they pass a quality test.”
Health Canada has asked Sanofi to advise Canadian doctors of the situation and suggest that patients who have concerns about taking the medication should speak with their health-care provider.
In addition, Health Canada said it would talk to international regulatory counterparts about the situation at hand and collaborate with ImmuCyst to solve issues at their plant.