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Dáil Éireann debate -
Tuesday, 25 May 1999

Vol. 505 No. 3

Written Answers. - Vaccination Programme.

Denis Naughten

Question:

150 Mr. Naughten asked the Minister for Health and Children if Trivax batch numbers 3753, 3797 and 3732 which were produced by the Wellcome Foundation were administered in Ireland in the late 1960s and early 1970s; the information, if any, he has received from Wellcome Foundation or Glaxo Wellcome Foundation in relation to these vaccine batches; and if he will make a statement on the matter. [13545/99]

Denis Naughten

Question:

152 Mr. Naughten asked the Minister for Health and Children if the Trivax three-in-one vaccine batches whose numbers range between 3753 and 3797, produced by the Wellcome Foundation were administered in Ireland in the late 1960s and early 1970s and if he will make a statement on the matter. [13547/99]

I propose to take Questions Nos. 150 and 152 together.

My Department has no information as to whether the Trivax vaccine batch numbers referred to by the Deputy were administered in Ireland in the late 1960s and early 1970s. However, correspondence is continuing with Glaxo Wellcome Limited, the successor to the company which produced the Trivax vaccine, in an effort to establish whether vaccine from batch 3732 and batches 3753 to 3797 might have been distributed in Ireland and, if so, whether the relevant lot numbers are available.

Glaxo Wellcome has previously indicated to my Department that a variety of tests were used to analyse Trivax in the late 1960s and that all batches of Trivax released for sale complied with the mandatory requirements at that time. The company added that the results of all tests, mandatory and otherwise, together with expert advice which the company had sought, indicate that no other batch gave rise to the same level of potential concern as batch 3741.

Denis Naughten

Question:

151 Mr. Naughten asked the Minister for Health and Children the number of children who had a severe reaction to Trivax three-in-one vaccine, batch numbers 84769, 84657 and 84019, which was administered in the Eastern Health Board area in 1972 and 1973; the other health boards, if any, which administered these vaccine batches; the reports, if any, of severe reactions; and if he will make a statement on the matter. [13546/99]

In the time available the Eastern Health Board has not been able to undertake a detailed examination of individual vaccination records for the period concerned. The information available indicates that in the board's area adverse reactions were noted in 73 children who were recipients of vaccine from the lots quoted. The number of children involved in each case was as follows: Lot 84019, 9 children; Lot 84657, 25 children; Lot 84769, 39 children.

It is not possible to classify these cases as to whether they were serious or non-serious, as it would appear that few, if any, were reported at the time to the National Drugs Advisory Board, now the Irish Medicines Board, which has a system of classification of the adverse reactions notified to it. It is known that four of the cases referred to above involved the hospitalisation of the child and as such would usually be classified as serious adverse reactions.

In so far as the other health boards are concerned, one board, the North-Western Health Board, has indicated that 41 children were vaccinated with Trivax, lot number 84657 in 1972/3 and that there are no records of any severe reactions in these cases. The Midland Health Board has indicated that it is unable to locate any records for the period concerned. The Western Health Board has not identified any records of usage of the vaccine numbers quoted. The board indicates that there are a number of records against which there are no batch numbers shown. The Mid-Western Health Board, the North-Eastern Health Board, the South-Eastern Health Board and the Southern Health Board have all indicated that an extensive examination of records would be necessary in order to ascertain whether vaccine from the lot numbers in question was used and that this was not feasible in the time available. The Irish Medicines Board has indicated that from 1972 to 1973 four suspected adverse reaction reports associated with the use of Trivax were notified to the board. No information was provided to the board as to the vaccine batch or lot numbers in these cases.

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