Page last updated at 06:47 GMT, Thursday, 26 February 2009

Vaccine pulled over bacteria fear

Vaccine and needle
Some 21,000 doses were removed from the shelves

Thousands of doses of the meningitis C vaccine have been withdrawn by the manufacturer Novartis following fears of contamination.

It is understood that the move was taken after samples from two batches were found to contain a bacterium.

The government's medicines agency said contaminated vaccine had not been distributed to the UK and the move was "entirely precautionary".

And there is "no reason" for UK children to be at any risk, it added.

Novartis said it was "committed to being a safe and reliable provider".

Some 21,000 doses in total have been removed from the shelves.

The recalled batches of the Menjugate Kit, which were manufactured in Italy, had passed safety checks before leaving the factory to be transported by road to the UK.

But a small number of samples were sent overseas by aeroplane to test whether the sample would remain secure under different air pressures.

At the destination, these were found to be contaminated with staphylococcus aureus bacteria, but never entered the supply chain.

GPs who received the batch which has been recalled have been contacted by the Department of Health.

Immunisation

The meningitis C vaccine is one of the routine immunisations in childhood, with the first doses normally given when a child is 3 and 4 months old.

A spokeswoman for the Medicines and Healthcare Products Regulatory Agency 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."

Dr Ged Lee, from the MHRA, stressed that the move was a precautionary one and that none of the samples that had come to the UK had been contaminated.

He said: "The batch that was contaminated I can reassure you was not distributed into the UK and I can also reassure parents that the product that has been used in the UK has passed all the necessary quality standards and is perfectly safe."

The Department of Health reiterated that the recall was a precautionary measure and added that anyone who was concerned after taking the vaccine should contact their GP or NHS Direct.

Steve Dayman, chief executive of Meningitis UK, said: "While this is worrying, we're pleased to hear Novartis is making every effort to recall the kit and investigate the root cause of the positive sterility test.

"Novartis has a reputation of being a safe provider of vaccines and it's important not to lose sight of how successful the meningococcal C conjugate vaccine has been.

"Incidences of death from this form of the disease have dropped by 90% in 10 years, saving hundreds of lives."

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