Doctors to find babies who had
By Steve Connor, Science Editor
Friday 27, February 2009
Doctors have been asked to trace all babies in Britain who have been injected in the past month with the meningitis C vaccine which was recalled on Wednesday after it emerged that it may be contaminated with a microbe that can cause potentially fatal blood poisoning.
The Department of Health also announced it is also going to test unused batches of the vaccine sent from Italy and stored in GP surgeries in the UK to see whether any of them are contaminated with Staphylococcus aureus, the same type of microbe responsible for the hospital-acquired infection MRSA.
The health department said it does not yet know how many of the 17,000 doses of meningitis C vaccine sent to GPs on 22 January and 20 February – but recalled on Wednesday night – have been used as part of the national childhood vaccination programme. However, it is likely to be in the hundreds or possibly thousands.
“We can, and are going to, track the vaccine to individual GP surgeries. GPs can then contact the patients who have had the injection. Although, as we’ve said, this is as a precautionary measure and we are not aware of any problems in the UK,” a spokeswoman for the health department said.
“We won’t know how many doses have already been administered and how many are sitting in GPs’ fridges until we have recalled them all. The health department has traced all the vaccine and knows where it is. It will be collected from GP surgeries,” she added.
Novartis, the Swiss pharmaceuticals company, manufactured its Menjugate vaccine for meningitis C at its facility in Italy, and the product destined for Britain had passed all sterility tests required under European Union regulations.
Daniel Vasella, CEO NOVARTIS
However, Novartis subsequently detected Staphylococcus contamination in samples taken from two batches that had already been sent to Britain by road. The samples were being used in an experiment to test their vulnerability to pressure changes when shipped by air and they were found to be positive on arrival in the US, a Novartis spokeswoman said.
Novartis informed the British distributor of the problem late on Friday night of last week by email, and the company subsequently telephoned the Department of Health on Monday morning, a spokesman said. The health department said it checked with the company on Monday morning to make sure it had informed the medicines watchdog, the Medicines Healthcare Products Regulatory Agency (MHRA) but the agency said that it was only told about the problem on Tuesday.
The MHRA recalled the vaccine on Wednesday night several hours after the health department had been approached by The Independent with questions about the possible contamination of the baby vaccine.
Professor Kent Woods, chief executive of the MHRA, said there was currently no evidence that any children have been harmed by the suspect stocks of meningitis C vaccine and there have been no reports of any infections following vaccination.
“Parents should not be concerned over this recall, as there is currently no evidence to show UK children have been put at risk. Novartis are recalling these two batches as a precautionary measure,” Professor Woods said.
More than 60,000 doses of vaccine formed the two batches sent from Italy. The Deparment of Health said that more than 21,000 of those had been shipped to GP surgeries but yesterday it revised that figure down to 17,000.
A spokeswoman for Novartis said the vaccine is transported in vials separated from a liquid solvent in which it is mixed on arrival. It was the liquid solvent – aluminium hydroxide – that was found to be contaminated. “The solvent that was transported by road to the UK passed all routine checks but the solvent that was transported by road and air to the US did not,” she said.