Frances Fitzgerald
Ceist:205 Ms Fitzgerald asked the Minister for Health and Children the concerns, if any, raised with him in relation to the MMR vaccine and its potential side-effects; and if he will make a statement on the matter. [6448/98]
Written Answers - Child Immunisation Scheme.
Frances Fitzgerald
Ceist:206 Ms Fitzgerald asked the Minister for Health and Children if he will provide scientific information on the trials which took place in this country before the MMR vaccine was introduced; and the duration of the trials. [6449/98]
Frances Fitzgerald
Ceist:207 Ms Fitzgerald asked the Minister for Health and Children his views on whether the MMR vaccines should be given one at a time rather than giving all three together in view of the concerns in the United Kingdom in relation to this vaccine; and if his Department will commission studies on the vaccine and its potential side effects. [6450/98]
I propose to take Questions Nos. 205, 206 and 207 together.
I am aware of reports of a recent study in the United Kingdom suggesting possible linkages between the MMR vaccine and autism. However, I have been advised that the Irish Medicines Board, along with other European regulatory authorities, and on the basis of the scientific data available, is of the view that no change in the regulatory status of the vaccine is warranted at this time. Nonetheless, the board has assured me that it will continue to monitor the situation and will take any appropriate action that may be considered necessary in the light of any information or evidence that might become available which would alter the risk-benefit ratio of the vaccine.
The vaccine in question has been licensed in Ireland for many year and is the subject of a current product authorisation issued by the Irish Medicines Board in accordance with the requirements of the Medical Preparations (Licensing and Sale) Regulations, 1996. The vaccine was first authorised following assessment by the former National Drugs Advisory Board, including assessment of the relative safety of the product. I am also advised that no clinical trials on this vaccine took place in Ireland before its introduction here. The clinical studies necessary to support the application for the licensing of the vaccine were conducted outside the country.
At present there is no scientific evidence to support the separate administration of these vaccines. The Immunisation Guidelines for Ireland, published in 1996 are currently being reviewed by the Immunisation Advisory Committee of the Royal College of Physicians of Ireland. All relevant scientific information relating to the safety and efficacy of the vaccines in use in the national immunisation programme is being considered by the committee, to ensure that the guidelines continue to reflect best international practice in his most important aspect of our preventive medical service.