Baby vaccine withdrawn over contamination fears
Thousands of doses of a meningitis C vaccine for babies have
been withdrawn over fears that they have been contaminated with
blood-poisoning bacteria.
Baby vaccine withdrawn over contamination fears
Thousands of doses of a meningitis C vaccine for babies have
been withdrawn over fears that they have been contaminated with
blood-poisoning bacteria.
More than 20,000 vials of the vaccine distributed to GP surgeries across the country have been recalled after samples tested positive for the bacteria Staphylococcus aureus.
It is thought that a further 40,000 doses could be contaminated with the hospital-acquired infection, but had not yet been sent to vaccination clinics when officials were alerted to the problem.
The Medicines and Healthcare products Regulatory Agency (MHRA) last night said that no children are believed to be at risk and emphasised that the doses had been recalled purely as a precautionary measure.
The vaccination, produced by Swiss pharmaceutical company Novartis, is offered to all four-month-old babies and has only been available in Britain since January.
Andrew Lansley, the shadow Health Secretary, last night described the incident as “very disturbing” and demanded an explanation from the government.
Novartis Vaccines and Diagnostics said it had been alerted to a sterility issue in the solvent for its Menjugate Kit, which is distributed to Britain from Italy.
The company confirmed last night that 61,117 doses of the vaccine could be contaminated.
It said that 21,301 of the doses have been sent to GP surgeries acros Britain over the past week for the Government’s childhood vaccination programme.
An MHRA spokeswoman said that some samples had tested positive for the bacteria, but these had not been brought over to Britain.
However, it was forced to recall the two batches which have been distributed for further tests to be carried out and comparisons to be drawn.
It is not known how many, if any, children have received the vaccine but there have not been any reports of adverse reactions.
The spokeswoman 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.
“Further investigations into the cause of the failure are under way by the company.
“There is currently no evidence to show that there is any risk to children.”
A spokeswoman for Novartis said: “Novartis is working with the relevant government authorities including the Medicines and Healthcare Products Regulatory Agency and the Italian Ministry of Health to recall two lots of Menjugate Kit distributed in the UK.
“We are investigating a sterility testing positive result from samples of one lot of Aluminum hydroxide solvent which was used for the packaging of two lots of Menjugate.
“The solvent lot passed all release specifications; the subject result was identified during a special study.”
The news comes amid scepticism from parents about childhood vaccinations following the unfounded scare over the measles, mumps and rubella (MMR) vaccine which was incorrectly linked to autism.
Mr Lansley said: “This is very disturbing news. We will be looking to the Government to give the fullest possible account of what’s happened.
“Parents who bring their children for immunisation need to have the greatest possible confidence that the vaccines concerned are safe and their children won’t come to harm. I will be looking to the Government to provide this specific assurance.”
Mike Penning, a Conservative health spokesman, said: “Parents take vaccines to make their children safe, not put them at risk.
“They will want answers as to why it took so long to withdraw the vaccine. The Government has got to come clean about its decision-making and when the Secretary of State was told what happened. We could need an independent inquiry to establish the facts.”
A Department of Health spokeswoman said last night: “We are aware that the Medicines and Healthcare Products Regulatory Agency has recalled two batches of meningitis C vaccine. This is as a precautionary measure and we are not aware of any problems in the UK.
“All batches of the vaccine that have come into the UK have passed all their tests including sterility.
“If people have had this vaccine recently and are concerned contact your GP or NHS Direct.”
http://www.cnn.com/2010/HEALTH/03/22/rotavirus.vaccine/?hpt=T2
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