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Information on Infanrix™hexa vaccine for parents of babies

October 11, 2012  

GlaxoSmithKline (GSK) has voluntarily recalled Infanrix™hexa vaccine lot # A21CB242A. This lot has been recalled as a precautionary measure only because tests indicated some bacterial contamination in the factory where the vaccine was made. Extra testing was done on this lot and there is no evidence that the vaccine itself was contaminated.  There is no safety risk to anyone who received this vaccine.  

Parents and guardians of children who received the recalled vaccine can be assured that their child has been immunized with an effective and safe vaccine. The recalled lot passed all tests related to safety and potency done by both the manufacturer and Health Canada.  

More than 20,000 doses of this vaccine have been given to babies in BC since April 2012. There have been no reports of problems with this vaccine that indicate bacterial contamination in BC or in the 1.2 million doses distributed around the world. The BC Centre for Disease Control (BCCDC) notified health authorities and other providers who order the vaccine directly from BCCDC on October 9th to remove the vaccine from use and return it for disposal. Alternate vaccine supplies are available.  

This vaccine is given to infants at 2, 4 and 6 months of age to protect against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and hepatitis B.  

Some parents planning to have their infants vaccinated in the next few days may need to reschedule their clinic visits in order to receive the Infanrix™hexa vaccine. Health care providers may also offer other vaccines such as Pediacel™ (which protects against diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b) and hepatitis B vaccine. These provide the same protection as Infanrix™hexa against the same diseases, but must be given by two separate injections. Both can be given at the same visit, along with the other vaccines recommended for the infant.  It’s important that children receive all of their immunizations on time.  

Your local public health unit can help you decide the best course of action.  

BCCDC regrets the inconvenience of this recall, but keeping infants healthy and safe is our priority.  

If your child received the recalled vaccine and you have any concerns, please contact your health care provider.   

For more information about BC’s immunization programs, visit www.immunizebc.ca
Last Updated: November 14, 2013