Martin issues Report on Use of Three-in-One Vaccine
The Minister for Health and Children, Micheál Martin, T.D., today (27 February 2001) issued a report on the usage in Ireland of Trivax three-in-one vaccine from the batch which was at issue in the case of Kenneth Best. In 1992 the Supreme Court found that the Wellcome Foundation was liable for the disability of Kenneth Best, who had been immunised with this product in 1969. The particular vaccine batch involved was number 3741, which had been produced in 1968 and is believed to have had a shelf-life of two years.
The Minister said that in the light of the Best judgement, he and his Department had been approached from time to time on behalf of a number of individuals, whose families believe that they may have suffered damage as a result of receiving three-in-one vaccine, seeking assistance in tracing the batch or lot numbers administered in these cases.
The Department has been in contact with the manufacturer of this product, and also asked the health boards to examine their records to establish what information is available. “Much of the information obtained about the usage in Ireland of vaccine from batch 3741 has already been placed in the public domain. The purpose of this document is to set out clearly and comprehensively the information obtained by my Department about the issues involved”, the Minister said.
The report issued by the Minister indicates that 296 individuals are recorded as having received vaccine from lots produced from batch 3741 in the period 1968-1971. The number of recipients in each of the health boards concerned (the Mid-Western, North-Western, Southern and Western Health Boards) is as follows:
|No. of persons||Period of usage|
|Mid-Western Health Board||183||October 1969 – October 1970|
|North-Western Health Board||3||November 1969 – February 1970|
|Southern Health Board||107||June 1969 – October 1971|
|Western Health Board||3||September 1969|
Full details are contained in the report. The other health boards did not succeed in tracing any records containing the lot numbers concerned. The report issued by the Minister is available here
The health boards had undertaken detailed searches of their records for a period which predated the establishment of the health boards. In many cases immunisation records for this period no longer exist, or where they exist do not contain vaccine lot numbers involved. It would appear reasonable, however, to assume that vaccine from the batch concerned was administered more widely than in the 296 cases documented in the records which have been traced.
The records obtained suggest that in some instances vaccine may have been administered after its expiry date. However it is difficult at this stage to be certain about this, as full information on the expiry date of all vaccine lots is not available.
The Minister said that he has written to the Chief Executive Officers of the four health boards concerned, asking them to endeavour to trace the individuals who received this product and to inform them accordingly.
The Minister added that the expert medical consensus is that wholecell pertussis vaccine has not been proven to be a cause of brain damage. He said that this view has been confirmed by the Immunisation Advisory Committee of the Royal College of Physicians of Ireland, which has stated that “although there has been controversy about pertussis vaccine the consensus from authoritative bodies is that it is a safe vaccine” (Immunisation Guidelines for Ireland, RCPI, 1996, p.25).