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Dáil Éireann debate -
Tuesday, 7 Nov 2000

Vol. 525 No. 2

Written Answers. - Vaccine Safety.

Jan O'Sullivan

Question:

192 Ms O'Sullivan asked the Minister for Health and Children the steps he is taking to reassure the public in relation to the safety of vaccines available having regard to reports that the United Kingdom plant which produces most vaccines available in Ireland was the subject of a critical report from the United States Food and Drug Administration; and if he will make a statement on the matter. [24546/00]

Among the essential elements for successful immunisation programmes is the availability of safe and effective vaccines in which the public can have complete confidence. In that regard, my Department is in regular contact with the Irish Medicines Board in relation to issues which arise from time to time in relation to vaccines used in public immunisation programmes in this country. In any case where the Irish Medicines Board advises that a product should not continue to be used, this is acted upon immediately by my Department.

The UK-based manufacturing plant which was the subject of a critical report from the United States Food and Drug Administration following an inspection carried out in July 1999, had also been inspected by the UK Medicines Control Agency. Both agencies independently arrived at similar conclusions. The manufacturing plant concerned has now put in place the necessary corrective actions to resolve the problems identified and both the Food and Drug Administration and the Medicines Control Agency are satisfied that the product concerned, 'flu vaccine, is safe.

The Irish Medicines Board maintains close liaison with the UK Medicines Control Agency in relation to the latter's monitoring of the manufacturing plant cited in recent reports. The Irish Medicines Board has been assured by the Medicines Control Agency that the vaccines manufactured at the plant concerned meet the appropriate standards. I will continue to liaise with the Irish Medicines Board in this matter.

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