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Meningitis Vaccine Being Recalled Over Sterility Issues

Posted Mar 03 2009 3:14pm

Reports are emerging that a Meningitis vaccine, made by Novartis Vaccines and Diagnostics Srl in Italy and distributed in the UK has been recalled due to sterility issue in the solvent.

So far, no children are considered to be at any risk from the solvent, according to the Medicines and Healthcare products Regulatory Agency (MHRA).

Reportedly the vaccines were only being taken back as a precaution.

A spokeswoman stated that there was a positive test result of the bacteria Staphylococcus aureus in some samples, but these had yet been to reach the UK.

However, she said tests are necessary on two further batches which have already been distributed with results and comparisons to be studied.

“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.

Approximately 20,000 vials are thought to have been sent out to doctors’ surgeries all over the UK, but how they have been spread out remains to be seen.

The vaccination has only been on the UK market since January.

The MHRA spokeswoman also stated,  “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.”

The Department of Health have added that they are unware of any issue with the vaccine in the UK and confirmed the recall was just 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.”

Andrew Lansley, the Shadow health secretary, said the Department of Health should take imminent steps to ease parents minds about the safety of the vaccine.

He said, “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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