(AFP) – Feb 25, 2009
LONDON (AFP) — Pharmaceutical giant Novartis said Wednesday it was recalling two batches of a meningitis C vaccine distributed in Britain over contamination fears, but regulators stressed the health risk was negligible.
Switzerland-based Novartis Vaccines and Diagnostics Srl said it had been alerted to a sterility issue in the solvent -- in which the vaccine is dissolved -- for its Menjugate Kit, distributed to Britain from Italy.
"We are investigating a sterility-testing positive result from samples of one lot of aluminum hydroxide solvent which was used for the packaging of two lots of Menjugate," a spokeswoman said.
Britain's drugs regulator said some samples had tested positive for the bacteria Staphylococcus aureus, which can cause skin infections, pneumonia and infection of the blood stream, but these had not been brought to Britain.
A spokeswoman for the Medicines and Healthcare products Regulatory Agency (MHRA) told AFP the risk to children was "negligible" and stressed the recall was purely a precautionary measure.
The vaccination has only been available in Britain since January, but it is thought that about 20,000 doses are being recalled.
The MHRA said in a statement: "There is currently no evidence to show that there is any risk to children."
Novartis said the affected samples had been tested and cleared for release, and the contamination was only revealed in a non-routine study.
It is investigating the failure and stressed it was "committed to being a safe and reliable provider of vaccines".
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