Health professionals and consumers are advised that, after consultation with the TGA, six batches of Infanrix hexa (AUST R 132881) have been recalled by the sponsor, GlaxoSmithKline Australia (GSK).
Infanrix hexa is a vaccine used to prevent six diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and Haemophilus influenzae type b (Hib).
It is given to children as part of the National Immunisation Program (NIP) and may be given to young children under the age of 8 years who have not been previously vaccinated.
This precautionary recall is being taken because a surface in the area where one of the manufacturing steps for the vaccine takes place was found to have a small amount of contamination with the bacterium Bacillus cereus, an organism commonly found in food and soil. No contamination of the ingredients or in the vaccine itself was found.
GSK has confirmed that the efficacy and safety of the vaccine remain unchanged, and it does not believe this issue poses a health risk to the children who have received it. All of the identified batches passed the quality assurance testing, including sterility testing, required for the vaccine to be released for use in Australia.
The affected batches are listed in the following table:
Batch number Expiry date
A21CB144A 31 January 2014
A21CB188D 31 January 2014
A21CB188E 31 January 2014
A21CB190A 31 January 2014
A21CB197A 31 January 2014
A21CB221B 31 January 2014
No other batches of Infanrix hexa or any other GSK vaccines distributed in Australia are affected by this recall.
GSK does not believe the potential for contamination poses a health risk to the children who have already received a dose from an identified batch.
The company maintains a worldwide database of adverse events reported for its medicines and vaccines, which includes Australian data. A search of this database has found no change in reporting patterns since the identified batches have been released. None of the reported adverse events have been directly linked to this issue.
All of the recalled batches were released in Australia between August 2011 and January 2012.
Health professionals are asked to isolate and not dispense or administer any doses from the recalled batches. GSK will provide replacement stock.
Patients who have already received doses from the recalled batches should be monitored as per routine post-immunisation processes. They do not need to be re-vaccinated.