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Meningitis vaccine withdrawn over bacteria fears

26 February 2009

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Batches of a meningitis C vaccine are being recalled by its manufacturer amid fears they have been contaminated with the bacteria Staphylococcus aureus.

The decision has been made after Novartis Vaccines and Diagnostics Srl were alerted to a sterility issue in the solvent for its Menjugate Kit, which is made in Italy but distributed throughout the UK, after some samples had tested positive for the bacteria.

A spokeswoman said the contaminated batches had not been sent to the UK. However the two batches, which have been distributed, are still being recalled for further tests.

She said: “The tested samples that failed the sterility test were part of a non-routine study undertaken by the company and were not part of the UK market product.”

The Medicines and Healthcare products Regulatory Agency (MHRA) said there is no evidence to suggest that any children are at risk and the drug has been recalled as a precautionary measure.

It added that none of the samples, which have only been available in the UK since January, which have been brought to the UK are contaminated.

It is believed the contamination may have occurred when Aluminum hydroxide solvent was used for the packaging of two lots of Menjugate.

Copyright © Press Association 2009

Medicines and Healthcare products Regulatory Agency