Manufacturer recalls tuberculosis vaccine
Recall comes one week after Nunavut began rationing supply of vaccine to newborns
The manufacturer of a tuberculosis vaccine is voluntarily recalling its product, a week after Nunavut began rationing its remaining supply to newborns.
Sanofi Pasteur stopped distribution of the BCG vaccine in April saying there was a problem with a final test the vaccine must pass.
In a press release announcing the recall, Health Canada said it believes problems at the company’s manufacturing facility in Ontario may have affected the vaccine’s quality.
The BCG vaccine is used to prevent serious complications of TB and is regularly given to First Nations and Inuit infants and newborns, particularly in Nunavut. The rate of TB in that territory is about 75 times the national average, according to the Canadian Medical Association.
Approximately 4,700 vials are on the market and are being immediately recalled.
Health Canada is looking for a replacement manufacturer. The agency said it’s working with Sanofi Pasteur to address the issues that lead to the recall.
For those who have recently received the vaccine, Health Canada said symptoms of a reaction include injection site soreness and mild irritation.
So far three people have reported adverse reactions to the Public Health Agency of Canada and Health Canada.
As of last week, Nunavut had enough vials to vaccinate about 400 newborns. The territory’s chief medical officer believed that would cover about half of the births expected this year.