GlaxoSmithKline ($GSK) has recalled a single batch in Canada of a children's vaccine that it had earlier recalled in Australia after finding bacteria in the plant where it was manufactured.
The company initiated the voluntary recall of one batch of the vaccine in Canada and 6 batches in Australia after discovering "a small amount of contamination with the bacterium Bacillus cereus" in the area where vaccine bulk antigens were kept, the notices to health officials said. Release tests, including sterility tests on intermediates and on the final containers met standards and "no contamination was found in the final product released for distribution," GSK reported. The vaccine, Infanrix hexa, can be given to children under 8, and is used to prevent 6 diseases: diphtheria, tetanus, whooping cough, hepatitis B, polio and Haemophilus influenzae type b (Hib).
The company told in-PharmaTechnologist that the vaccine was manufactured at a plant in Rixensart, Belgium. GlaxoSmithKline said in its notices that the batches in the recall passed quality assurance testing and the company doesn't believe children who have already been given the vaccine are at any risk. Its database of adverse events has turned up no indication of problems and the recall was undertaken as a precaution.
The recall is only the most recent in a number of vaccine issues in recent months. Most recently, a decision by Italy to ban some Novartis ($NVS) flu vaccine set off a chain reaction by authorities in Canada, Singapore and a string of European countries to hold up use. Authorities in Canada, Switzerland and Singapore reversed their decisions after getting more details from Italy and Novartis that the company pulled one batch of the vaccine after discovering elevated levels of protein aggregates. A spokeswoman for Novartis said the company continues to work with the European countries to allay their concerns.
In July, the FDA released a warning letter that laid out two dozen observations at a Sanofi Pasteur plant in Canada concerning mold and contamination problems that led the company to close some operations, a move that led to a shortage of BCG tuberculosis vaccine in some countries.
- see the Health Canada notice
- get the Australia notice
- read the in-PharmaTechnologist story