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Dáil Éireann díospóireacht -
Thursday, 8 Oct 1998

Vol. 494 No. 6

Written Answers. - Vaccination Programme.

Alan Shatter

Ceist:

86 Mr. Shatter asked the Minister for Health and Children the outcome of the inquiries initiated relating to the administration of the three in one vaccine supplied by a company (details supplied) derived from batch number 3741 which failed two laboratory tests for potency and toxicity; the number of children who were recipients of vaccine from this batch; the responses to date received by his Department from each of the health boards to whom inquiries concerning this matter were made; the investigations conducted to identify whether applicants and recipients of ex gratia payments in the past were immunised with vaccine derived from this batch; and the explanation, if any, given by the company for its failure to furnish his Department with information a number of years ago advising it of the toxicity of this batch. [19035/98]

In the light of the outcome of the Supreme Court case in 1992, my Department requested the health boards to examine their records in an effort to establish the extent to which they contained information on the use of Trivax vaccine from batch 3741, which was the batch cited in the case. The boards' records did not enable the extent of usage of the batch to be established at that time. Information later obtained from the manufacturer indicates that the batch of this number was produced in 1968 and that it was dispensed into nine transit jars. Three of these jars were not sold as Trivax. The remaining six jars were filled into single and ten-dose containers for distribution in various countries, including Ireland and in the course of this various identifying lot numbers were assigned. On receipt of the information in regard to these, my Department wrote to the health boards, asking them to re-examine their records in detail in an effort to ascertain the extent of use of these lot numbers during the 1968-70 period in the areas over which they have jurisdiction. It must be recognised that immunisation records, where they exist for the period in question, may not be complete and that it may prove difficult, if not impossible, to identify the vaccine lot administered in any particular case.

To date, responses have been received from the Mid-Western Health Board and in respect of part of the Western Health Board which indicate that vaccine from the lots in question was administered in 184 cases. The records available to my Department at present indicate that only one of the applicants to the expert group which considered cases of alleged vaccine damage had received vaccine derived from the batch in question. This applicant was the individual in respect of whom the Supreme Court later found that the manufacturer of the Trivax vaccine was liable for his brain damage. The Trivax batch in question had passed the mandatory tests carried out by virtue of the licence held under the Therapeutic Substances Act, 1932. Information on the outcome of certain guidance testing conducted at the time was presented in the court during this case. The tests in question were undertaken in conjunction with the World Health Organisation for the purposes of developing better and more sensitive tests for the future.

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