A VACCINE routinely given to babies in their first six months has been recalled in Australia over concerns about bacteria found in the Belgian factory where it was made.
About 115,000 doses of the Infanrix hexa vaccine have been recalled because of potential contamination, but health authorities say there is no need for parents to be concerned because none of the bacteria have been found in the vaccines.
The vaccine, supplied by GlaxoSmithKline Australia, is given to about 300,000 babies each year to protect them against six diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and Haemophilus influenzae type b (Hib).
It is usually given to infants in three doses at two, four and six months as part of the National Immunisation Program. Older children under eight are also given the vaccine if they have not previously received it.
The bacteria found in the factory, Bacillus cereus, is generally found in food and soil and can be toxic for humans, causing diarrhoea and vomiting.
The medical director of vaccines at GlaxoSmithKline Australia, Dr Mark Ames, said the recall involved about 115,000 vaccines in six batches dispatched around Australia between August 2011 and January this year. They make up about one-10th of the 1 million doses given to Australian babies each year.
Dr Ames said while health professionals were being asked to stop using these vaccines a ''significant proportion'' of them had already been used.
He said there was no need for parents to worry about this because the vaccines had been subjected to stringent testing that found no trace of the bacteria. Furthermore, there had been no change in adverse reactions in babies linked to the vaccine.
''This is really being done as a precaution, not specifically because we believe there is a safety problem for patients,'' he said.
Australia's drug regulator, the Therapeutic Goods Administration, has backed the advice, saying parents do not need to worry. ''If a child has received a dose from one of the identified batches, he or she does not need additional monitoring and does not need to be revaccinated,'' a TGA spokeswoman said.
''Parents who have any questions or concerns about this issue should talk to their immunisation provider or other health professional.''
A spokesman for GSK said it acted quickly to recall the products over about 11 days. He said the potential contamination was confirmed at the manufacturing site on September 28 with a decision to recall them made on October 4.
''GSK Australia was informed of the issue on Sunday, October 8. GSK informed the TGA of the issue on Monday, October 9, and began the recall process,'' he said.
Any adverse events following immunisation should be reported to GSK Medical Information on 1800 033 109 and state health departments.