Information update – Sanofi Pasteur recalls tuberculosis (BCG) vaccine
OTTAWA, June 15, 2012 /CNW/ – Health Canada is advising Canadians that
Sanofi Pasteur is voluntarily recalling all Bacille Calmette-GuÃ©rin
(BCG) vaccine on the market because of problems in the manufacturing
facility that Health Canada believes may have affected the vaccine
BCG is used to prevent serious complications of tuberculosis (TB)
infection, notably for infants and children living in First Nation and
Inuit communities at high risk for tuberculosis outbreaks. It is not
widely used in Canada and does not prevent TB infection in someone who
has already been exposed.
Approximately 1,000 vials of the vaccine have already been kept out of
circulation by Sanofi Pasteur, and roughly another 4,700 vials on the
market are being immediately recalled.
The Public Health Agency of Canada is investigating options to replace
the BCG vaccine. 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.
For infants who will not be given the BCG vaccine due to this recall,
Health Canada staff and community health care workers will continue to
provide strong TB program services, ensuring measures are in place to
protect children at risk of exposure to TB. Antibiotic treatments are
available on the Canadian market to treat tuberculosis even in very
For those who have recently received the vaccine, the symptoms of a
reaction related to the manufacturing problems would likely be mild and
would occur within a few days of receiving the vaccine. They would
include injection site soreness and mild irritation. Consult with your
healthcare practitioner if you are concerned about your health or your
child’s health after receiving the BCG vaccine.
Three adverse reactions potentially linked to the recalled vaccine lots
have been reported to the Public Health Agency of Canada and Health
Canada, and all were the kind of mild reactions normally associated
with this vaccine.
Health Canada continues to work with Sanofi Pasteur to address the
issues in the manufacturing facility that lead to these actions.
Consumers requiring more information about this advisory can contact
Health Canada’s public enquiries line at (613) 957-2991, or toll free
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SOURCE Health Canada