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Dáil Éireann debate -
Tuesday, 6 Mar 2001

Vol. 532 No. 1

Written Answers. - Vaccination Programme.

Denis Naughten

Question:

219 Mr. Naughten asked the Minister for Health and Children the actions taken by his Department or the Irish Medicines Board to trace the batches produced by a company (details supplied) and the people administered with the suspect vaccine following the announcement by him in December 2000 relating to the polio vaccine; and if he will make a statement on the matter. [6813/01]

Denis Naughten

Question:

220 Mr. Naughten asked the Minister for Health and Children if, following an investigation of the polio vaccine of a company (details supplied) it was established that some of these vaccines were administered after the expiry date of the vaccine batch, the number of people who received expired vaccine; and if he will make a statement on the matter. [6814/01]

Denis Naughten

Question:

221 Mr. Naughten asked the Minister for Health and Children if his attention has been drawn to the administration of expired polio vaccine to individuals; the numbers who were made aware of this fact and were called back for re-vaccination; the numbers who were subsequently re-vaccinated; and if he will make a statement on the matter. [6815/01]

I propose to take Questions Nos. 219 to 221, inclusive, together.

On 13 December 2000 the Irish Medicines Board informed my Department that a constituent of the oral polio vaccine, namely human serum albumin, HSA, utilised a blood donation in its manufacture from a UK resident who has recently been diagnosed as having the variant form of Creutzfelt Jakob Disease vCJD. On receipt of the information I arranged to obtain expert advice from both national and international experts in the field, who advised on a wide range of aspects relating to this issue. Their advice indicated that the potential risk, if any, to recipients is essentially non-existent.

In conjunction with making the public information in this regard, each health board was asked to establish a telephone line which parents could call if they wished to obtain information or to discuss any concerns about their children, arising from the announcement. This service also enabled reassurance to be given to parents about the level of risk involved. The telephone helplines were in operation from 19 December and there was a high volume of calls to these lines in the days immediately following the announcement. The helplines in most regions were discontinued in early January, as the number of calls being received had declined to a very low level.

Health boards were requested to have immunisation records examined in order to establish the extent of usage of the vaccine batches concerned. In the course of this examination, information came to light which suggested that vaccine from the batches concerned was administered after its expiry date. Health boards were also requested to establish the extent to which this occurred. To date, responses have been received from five health boards, which indicate that, in four health boards 4,225 doses were administered out of date. In the fifth board, 295 children received out of date vaccine. Children receive three doses of oral polio vaccine as part of their primary immunisation and one booster dose at school entry age. In any 12 month period, some 100,000 children would receive primary and booster polio immunisations.

I sought expert advice in relation to the safety and efficacy aspects of this issue from the immunisation advisory committee of the Royal College of Physicians of Ireland. The committee advised that the efficacy of the vaccine is reduced if it is administered more than one month after the expiry date and that the vaccination should therefore be repeated in such cases. My Department wrote to the chief executive officers of the health boards, advising them that parents of any children who received any dose of oral polio vaccine more than one month after its expiry date, should be contacted and advised of the need to have the immunisation repeated. The health boards were also asked to advise general practitioners and all other relevant health professionals of the situation. It is not possible at this stage to indicate the number of children who have been re-vaccinated. This information has been requested from the health boards.
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