Nunavut’s TB vaccine stocks run dry in wake of manufacturer recall
“Our vaccination program with BCG is suspended until further notice”
In a territory where new cases of tuberculosis are diagnosed at a rate that ranges up to 60 times higher than the rest of Canada, supplies of a TB vaccine given to most Nunavut infants have dried up.
All stocks of BCG vaccine, offered to all babies born in Nunavut to protect them against the most dangerous forms of tuberculosis, are being voluntarily recalled by the manufacturer, Sanofi Pasteur, the Nunavut Department of Health and Social Services announced June 15.
Health Canada announced earlier on June 15 that the company has withdrawn 4,700 vials of the vaccine from circulation. The company withdrew 1,000 vials from circulation this past April.
“We’ve taken immediate steps to remove the product from all communities and as of today our vaccination program with BCG is suspended until further notice,” Maureen Baikie, deputy chief medical officer of health for Nunavut, said in a press conference June 15.
All babies in Nunavut are offered BCG immunization under the territory’s tuberculosis program.
The Bacille Calmette-Guérin or BCG vaccine offers an 80 per cent protection against TB for 15 years.
“I don’t have specific numbers on coverage rate, my understanding is there is good uptake,” Baikie said.
Use of the BCG vaccine has been discontinued in most of southern Canada, where TB is rare. But it continues to be used in regions where the TB infection rate is high, such as Nunavut, the Northwest Territories and most recently in Nunavik.
Nunavik public health officials recently decided to start vaccinating all children born before 2004 in the community of Kangiqsualujjuaq where a TB outbreak has seen nearly 60 people diagnosed with active TB since November 2011.
Health Canada said Sanofi Pasteur withdrew the vaccine “because of problems in the manufacturing facility that Health Canada believes may have affected the vaccine quality.”
At the same time, Health Canada said babies vaccinated with the recalled product are at low risk of developing complications, she said.
Any symptoms would likely be mild and would occur within a few days of receiving the vaccine, Baikie said.
“We’re taking further steps to advise parents of the babies who received this product about that,” she said.
The BCG product that’s being circulated in Nunavut has been in the territory since July 2011.
“So we have a time frame on which to look back at our records,” Baikie said.
Baikie did not know when the last dose of the vaccine was given.
Health Canada said officials with the Public Health Agency of Canada are now scrambling to find an alternate BCG vaccine supplier, but did not say when.
“Health Canada will use all of the regulatory tools at its disposal to make a replacement vaccine available while ensuring that safety is not compromised,” Health Canada said.
That means they may look outside the country for supplies, Baikie said.
Adverse effects following immunization are reported to the chief medical officer in Nunavut. The reports are reviewed and then sent to the public health agency.
The Department of Health and Social Services reviewed reports from the last two years, Baikie said. “We’ve had no baby in Nunavut with a reported adverse reaction to this vaccine that’s recalled today.”
“This vaccine doesn’t prevent people from getting TB, but it helps to prevent the more serious TB that children might get, including TB meningitis,” she said.
In Nunavut there are about 800 births a year, Baikie said.
This past March 22, the governments of Canada and Nunavut announced new money to combat tuberculosis.