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Vaccine pulled over bacteria fear | Vaccine pulled over bacteria fear |
(40 minutes later) | |
Thousands doses of the meningitis C vaccine have been withdrawn by the manufacturer Novartis as a precaution following fears of contamination. | Thousands doses of the meningitis C vaccine have been withdrawn by the manufacturer Novartis as a precaution following fears of contamination. |
It is understood that the move was taken after samples from two batches were found to contain a bacterium. | 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 there had been no reports of adverse reactions and it did not believe children in the UK were at risk. | The government's medicines agency said there had been no reports of adverse reactions and it did not believe children in the UK were at risk. |
Novartis said it was "committed to being a safe and reliable provider". | Novartis said it was "committed to being a safe and reliable provider". |
The firm said said it had been alerted to a sterility issue in the solvent for its Menjugate Kit, which is manufactured in Italy and has only been available in the UK since January 2009. | The firm said said it had been alerted to a sterility issue in the solvent for its Menjugate Kit, which is manufactured in Italy and has only been available in the UK since January 2009. |
Factory tests | Factory tests |
Some 21,000 doses in total have been removed from the shelves. | Some 21,000 doses in total have been removed from the shelves. |
The batches found to contain the bacteria Staphylococcus aureus had been transported by air. | |
The rest of the batches, transported by road, had passed all the factory tests. | The rest of the batches, transported by road, had passed all the factory tests. |
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." | 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 said in a statement that the move was a "precautionary measure", adding that anyone who was concerned after taking the vaccine should contact their GP or NHS Direct. | The Department of Health said in a statement that the move was a "precautionary measure", adding that anyone who was concerned after taking the vaccine should contact their GP or NHS Direct. |