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| Version 3 | Version 4 |
|---|---|
| Vaccine pulled over bacteria fear | Vaccine pulled over bacteria fear |
| (about 2 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| Thousands of doses of the meningitis C vaccine have been withdrawn by the manufacturer Novartis following fears of contamination. | Thousands of doses of the meningitis C vaccine have been withdrawn by the manufacturer Novartis following fears of contamination.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." | |
| 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. | 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. | "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." | "Incidences of death from this form of the disease have dropped by 90% in 10 years, saving hundreds of lives." |