A baby vaccine supplied by GlaxoSmithKline Australia ($GSK) has been recalled over concerns about bacteria found in the Belgian factory where it was made.
About 115,000 doses of Infanrix hexa vaccine--which protects against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b--were recalled due to potential contamination, The Sydney Morning Herald reports. A species of bacteria found in the factory, Bacillus cereus, is generally found in food and soil, but can cause vomiting and diarrhea in humans.
The pharma giant is working to recall the 6 batches dispatched between Aug. 2011 and Jan. 2012 as a precautionary measure. During testing, GSK found a low level of contamination during one step of the vaccine manufacturing process.
"Based on release specifications and safety report monitoring, GSK believes the effectiveness and safety profile of the vaccine remains unchanged," Andrew Yeates, GSK medical director, said in a press release. "We also believe this issue poses no health risk to patients. This voluntary recall is being taken solely as a precautionary measure."
The vaccine is given to about 300,000 babies each year.
- see the Glaxo release
- get more from The Sydney Morning Herald