カナダにて、サノフィのBCGワクチン供給停止・リコール

カナダにて、サノフィのBCGワクチン供給停止の報道。 http://www.cbc.ca/news/health/story/2012/06/22/north-tb-vaccine-update.html

No TB vaccine until 2013 says Canadian company

BCG vaccine used in Nunavut to protect newborns

CBC News 

Posted: Jun 22, 2012 12:39 PM ET 

Last Updated: Jun 22, 2012 1:22 PM ET

The Canadian manufacturer of the BCG tuberculosis vaccine says it won't be making more until late 2013.

The vaccine is offered to newborns in Nunavut and helps protect against serious forms of the disease for two years. The rate of TB in Nunavut is about 75 times the national average, according to the Canadian Medical Association.

Sanofi Pasteur, the manufacturer of the BCG vaccine, estimates production will resume in late 2013 after renovations to its Ontario manufacturing facility are completed. (CBC)

Sanofi Pasteur, the only Canadian company that makes the BCG vaccine, stopped distributing it in April.

Nunavut was rationing its remaining supply of the vaccine when themanufacturer recalled the remaining vialslast Friday as problems at the company’s manufacturing facility in Ontario may have affected the vaccine’s quality.

The company said the vaccine is unavailable due to renovations in the Ontario plant to improve quality management.

The federal government is currently looking at international suppliers for the vaccine. Health Canada said earlier this week the department had contacted five international manufacturers of BCG and has already heard back from some, but could not say when a new supply of the vaccine would be available.

カナダでのサノフィ社BCGワクチンのリコール。 http://www.cbc.ca/news/canada/north/story/2012/06/15/north-tuberculosis-vaccine-recall.html

Manufacturer recalls tuberculosis vaccine

Recall comes one week after Nunavut began rationing supply of vaccine to newborns

CBC News 

Posted: Jun 15, 2012 4:19 PM CT 

Last Updated: Jun 15, 2012 4:41 PM CT

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.