Parents told not to worry after infant vaccine is recalled

A VACCINE routinely given to babies in their first six months has been recalled in Australia due to concerns about bacteria found in the Belgian factory where it was made.

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.

About 115,000 doses of the Infanrix hexa vaccine have been recalled because of potential contamination but health authorities said the bacteria had not been found in the vaccines to date.

Supplied by GlaxoSmithKline Australia, the vaccine is given to about 300,000 babies in three doses 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 babies at two, four and six months as part of the federal government's National Immunisation Program.

The medical director of vaccines at GlaxoSmithKline Australia, Mark Ames, said the recall involved about 115,000 vaccines dispatched around Australia between August last year and January this year. The recalled batches make up about one tenth of the 1 million doses given to Australian babies each year.

Dr Ames said while health professionals were being asked to isolate these vaccines and stop using them, he believed a ''significant proportion'' of them had already been used.

He said there was no need for parents to worry because the vaccines had been subjected to stringent testing which 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,'' 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 re-vaccinated,'' a Therapeutic Goods Administration spokeswoman said.

''Parents who have any questions or concerns about this issue should talk to their immunisation provider or other health professional.''

Any adverse events following immunisation should be reported to the GlaxoSmithKline Medical Information department on 1800 033 109 and state health departments.

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