Press Association 

Contamination fears prompt meningitis C vaccine recall

• Sterility issue in solvent for Italian medicine• Watchdog says no children believed to be at risk
  
  


A drugs company has recalled batches of a meningitis C vaccine due to contamination fears.

Novartis Vaccines and Diagnostics said it had been alerted to a sterility issue in the solvent for its Menjugate Kit, which is from Italy and distributed in the UK.

The Medicines and Healthcare Products Regulatory Agency (MHRA) said no children were believed to be at risk from the solvent and emphasised it had been recalled purely as a precautionary measure.

A spokeswoman said some samples had tested positive for the bacteria Staphylococcus aureus, but these had not been brought over to the UK.

However, the two batches which had been distributed had to be recalled for further tests to be carried out and comparisons to be drawn.

"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 spokeswoman said.

Around 20,000 vials are believed to have been distributed to doctors' surgeries around the country, but it is not known how they have been spread out.

The vaccination has only been available in the UK since January.

The MHRA spokeswoman said: "Further investigations into the cause of the failure are under way by the company.

"There is currently no evidence to show that there is any risk to children."

A spokeswoman for Novartis said: "Novartis is working with the relevant government authorities including the Medicines and Healthcare Products Regulatory Agency and the Italian ministry of health to recall two lots of Menjugate Kit distributed in the UK.

"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.

"The solvent lot passed all release specifications; the subject result was identified during a special study."

She said the company was "committed to being a safe and reliable provider of vaccines".

A Department of Health spokeswoman said it was not aware of any problems with the vaccine in the UK and described the recall as a precautionary measure.

"All batches of the vaccine that have come into the UK have passed all their tests, including sterility.

"If people have had this vaccine recently and are concerned, contact your GP or NHS Direct."

The shadow health secretary, Andrew Lansley, said the department should act urgently to reassure parents about the safety of the vaccine.

"When parents take their children for vaccinations it is essential that they are confident that the vaccine is safe. I hope that ministers will provide that reassurance as quickly as possible."

 

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