Sanofi recalls TB vaccine over quality issues; Canada scrambles for new supply

TORONTO – Sanofi Pasteur is recalling all doses of its tuberculosis vaccine from the Canadian market because of concerns over the quality of the vaccine.

Health Canada is announcing the recall, saying problems at Sanofi’s manufacturing facility may have affected the quality of its vaccine.

About 4,700 vials that have been distributed are being pulled back; the company already held back another 1,000 vials of the product.

The vaccine is not widely used in Canada.

It’s mainly used to prevent serious complications of tuberculosis infection for infants and children living on First Nations and Inuit communities that are at high risk for TB outbreaks.

Sanofi is the sole supplier of this type of vaccine in Canada.

The Public Health Agency of Canada is investigating options to replace the vaccine, called Bacille Calmette-Guérin (BCG) vaccine.

Health Canada says it will use all regulatory tools at its disposal to expedite approval of an alternative vaccine.

Health Canada’s release does not say how the problem came to light or what kinds of manufacturing problems were behind the recall.

But it says 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, the department says.