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Vaccine pulled over bacteria fear | Vaccine pulled over bacteria fear |
(about 3 hours later) | |
Thousands of doses of the meningitis C vaccine have been withdrawn by the manufacturer Novartis following fears of contamination. | Thousands of doses of the meningitis C vaccine have been withdrawn by the manufacturer Novartis following fears of contamination.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. | 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". | 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. | 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". | Novartis said it was "committed to being a safe and reliable provider". |
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 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. | 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 transported to another country by air, were later found to be contaminated with staphylococcus aureus bacteria. | But a small number of samples transported to another country by air, were later found to be contaminated with staphylococcus aureus bacteria. |
Immunisation | 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. | 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." | 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. | 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." | 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. | 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." |