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Health: Meningitis C Vaccine

Volume 708: debated on Friday 27 February 2009


My right honourable friend the Minister of State, Department of Health (Dawn Primarolo) has made the following Written Ministerial Statement.

On 25 February, and in consultation with the Medicines and Healthcare products regulatory Agency (MHRA), Novartis Vaccines and Diagnostics issued a precautionary recall of two batches with a total of 17,000 doses of a meningitis C vaccine Menjugate Kit. A potential problem has arisen with the solvent that is used to reconstitute the vaccine before it is administered. This follows the detection of the staphylococcus aureus bacteria in part of a batch manufactured in Italy but which did not reach the UK. All batches of the vaccine that have come into the United Kingdom have passed all their tests, including sterility.

The MHRA has reassured me that parents need not be concerned over this recall, as there is currently no evidence to show that UK children have been put at risk. However, if parents are in any way concerned, they should consult their doctor about the issue or contact NHS Direct.

The MHRA has received no reports of infections following vaccinations. There is also no current evidence to suggest that UK children have been given a contaminated vaccine.

Further investigations into the incident are under way by Novartis. Tests have also begun on batches in the UK.

We will provide a further statement to the House when the necessary investigations have been completed.