Sanofi, Sole Supplier of TB Vaccine in Canada, Recalls 47,000 Doses

Health Canada has announced a vaccine recall due to possible vial contamination in the wake of a flood last year at a plant in Canada.  The plant is the sole supplier of a tuberculosis vaccine and has recalled all doses because of safety concerns.

Health Canada announced that Sanofi Pasteur was recalling roughly 4,700 vials — or 47,000 doses — of the BCG vaccine. BCG stands for Bacille Calmette-Guerin, named after Albert Calmette and Camille Guerin who developed the live-bacteria vaccine in the early 1900s.

There were another 1,000 vials produced as part of the affected lots, but they had not been distributed by the company.

The concerns came to light following routine inspections of the company’s Toronto manufacturing facility in May and early June, a senior Health Canada official said in an interview.

Dr. Paul Gully said the building in which the vaccine is made was flooded last October, and there remain ongoing production challenges related to the flood.  “It made Health Canada concerned there is a possibility of contamination,” said Gully, senior medical adviser to the deputy minister of Health Canada. Gully said, though, that testing so far has not identified any contaminated product.

Three adverse reactions potentially linked to the recalled vaccine lots have been reported. All were the kind of mild reactions normally associated with this vaccine, Health Canada said.

Even though this particular plant manufactures other vaccines only the BCG vaccine is made in the affected building.

BCG is also used as a treatment for bladder cancer. The bladder cancer product is made in the same building as the vaccine, but those lots are not being recalled.

Apparently according to a Health Canada advisor, the risk-benefit ratio is different when one is trying to prevent serious disease (in the case of the vaccine) versus when one is trying to treat it (the bladder cancer).

Health Canada has reached out to five other manufacturers that make BCG vaccines.  None of them has a license to market TB vaccine in Canada, but there are means by which vaccine approvals can be expedited under circumstances like this. Some of the products have been pre-approved by the World Health Organization, Gully said.

How long the country will be without tuberculosis vaccine is unclear at this point.  “I can’t give you a time frame because it does take time to do this,” Gully said.

The vaccine is not widely used in Canada. It is mainly employed to protect young children living in First Nations and Inuit communities where the risk of TB outbreaks is high.

BCG is not considered a very good vaccine, said Dr. Michael Gardam, director of the tuberculosis clinic at Toronto’s University Health Network. It does not prevent infection.

But young children who receive it have a lower risk of developing severe disease — tuberculosis meningitis or disseminated TB — if they become infected.

Gardam said the recall is an inconvenience, but is unlikely to trigger a public health crisis.  Even the jurisdiction with Canada’s worst TB problem — Nunavut — seemed to be taking the recall in stride.

Dr. Maureen Baikie, deputy chief medical officer for Nunavut, said the territory had returned all BCG vaccine and suspended its vaccination program.  It is also informing the parents of children who received vaccine from the recalled lots, she said.


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