Thousands of doses of a meningitis C vaccine are being recalled after a contamination scare.
Drugs
firm Novartis Vaccines and Diagnostics Srl said it had been alerted to
a sterility issue in the solvent for its Menjugate Kit, which is from
Italy and distributed in the UK.
The Medicines and Healthcare products Regulatory Agency (MHRA) said no children are believed to be at risk from the solvent.
It said the vaccines had been recalled purely as a precautionary measure.
A
spokeswoman said some samples had tested positive for the bacteria
Staphylococcus aureus, but these had not been brought over to the UK.
However,
she said two batches that have already been distributed have had to be
recalled for further tests to be carried out and comparisons to be
drawn.
"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," the spokeswoman
said.
Around 20,000 vials are believed to have
been distributed to doctors' surgeries around the country, but it is
not known how they have been spread out.
The vaccination has only been available in the UK since January.
The MHRA spokeswoman added: "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
Department of Health spokeswoman said it was not aware of any problems
with the vaccine in the UK and described the recall as a "precautionary
measure".
"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."
Shadow health secretary Andrew
Lansley said the Department of Health should act urgently to reassure
parents about the safety of the vaccine.
He
said: "When parents take their children for vaccinations it is
essential that they are confident that the vaccine is safe. I hope that
ministers will provide that reassurance as quickly as possible."