Press release: No evidence of any risk to UK children over meningitis vaccine

Press release

Date:	26 Feb 2009
Time:	16:00
Subject:	Recall of Menjugate Kit vaccine
Contact:	Press Office 020 7084 3651 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) yesterday issued a precautionary drug alert for two batches of Menjugate Kit (a meningitis vaccine made by Novartis) from GP surgeries, with a total of 17,000 doses.

There is currently no evidence of any risk to UK children, and there have been no reports of any infections following vaccination.

The two batches sent to the UK passed all the normal tests, including a sterility test, to ensure the safety, quality and effectiveness of the product before leaving the manufacturing site in Italy and travelling by road to the UK.

Individual GP practices that received vaccine from these batches have been contacted by the Department of Health to recall them.

Professor Kent Woods, MHRA Chief Executive, says: “Parents should not be concerned over this recall, as there is currently no evidence to show that UK children have been put at risk. Novartis are recalling these two batches as a precautionary measure.

However, if parents are in any way concerned, then they can contact their doctor about the issue or contact NHS Direct.”

Novartis sent samples from the same batches overseas to test whether the sample would remain secure under the varying air pressure. The samples, which passed sterility tests before transportation, were re-tested when they reached their destination. These samples tested positive for Staphylococcus aureus bacteria. They were quarantined by Novartis and did not enter into any supply chain.

The batches sent to the UK were transported by road (their normal transportation method) and have not been exposed to the air pressure testing.

Further investigations into the cause of the test results from the samples sent to the US are underway by the company. Tests have also begun on batches in the UK.

The MHRA was first alerted by Novartis on 24 February 2009 that there was a sterility issue with the solvent in the Menjugate Kit from the US samples. The solvent is used to mix the meningitis vaccine.

Notes to Editor

1. What action should be taken if a child has recently had a MenC vaccine? Other meningitis vaccines, and other batches of Menjugate, are not affected by this recall.

2. Product name ‘Menjugate Kit’; batch numbers 236011 and 235012A

3. The figure has is now 17,000 doses rather than the 21000 doses used yesterday. 17000 doses from these batches of vaccine have been distributed to GPs. We found out today that the 21000 figure included stock that had been distributed and stock that was waiting to be sent out.

4. A copy of the drug alert can be found at our website: http://www.mhra.gov.uk/Publications/Safetywarnings/Drugalerts/CON038882