Dáil Éireann debate -
Wednesday, 21 Mar 2001

Vol. 533 No. 1

Adjournment Debate. - Vaccine Toxicity.

Mr. Naughten

I thank you, Sir, for giving me the opportunity to raise this matter and I thank the Minister for his attendance. On 27 February he announced that he had directed the health boards to trace the 296 children immunised with the Kenneth Best vaccine, Trivax DTP vaccine batch 3741. At the time when the vaccine was being administered in the late 1960s and early 1970s, there was a huge upsurge in the number of severe reactions in children who received the Trivax vaccine. Serious questions overhang the vaccine and its manufacture, so much so that the late Mr. Justice Liam Hamilton in the Best case described Glaxo Wellcome, the manufacturers of the vaccine, as negligent and criticised the company's quality control procedures.

While the announcement by the Minister to contact the children administered with vaccine batch 3741 is welcome, why is the same not to be done with other suspected batches? Why is the Department continuing to rely solely on the information provided by Glaxo Wellcome to substantiate the claim that no other batches gave rise to the same level of potential concern? Had it not been for Margaret Best would the same response not continue to be forthcoming from Glaxo Welcome in relation to vaccine batch 3741?

During the Kenneth Best case, when questioned under cross examination by Mr. Dermot Gleeson as to whether other batches of similar or greater potency were released, Mr. Peter Knight, manager of the immunological product support group of the Glaxo Wellcome Foundation stated:

"There may have been a half dozen, a dozen or a 100 more. . . Goodness knows what I would have found if I had looked wider."

Does this not give rise to the same level of potential concern as vaccine batch 3741?

At approximately the same time as this batch was being released and administered, another batch of greater potency, batch 3732, was also released. This batch was 16 times greater than the British standard at that time. Batch 3741 was 14 times greater.

From May 1968, 14 batches of vaccine which were not subjected to the mouse weight gain test were released. This was a standard test at the time, both in the US and the WHO. Such tests were administered from January 1969 and January 1970. During the period there was an enormous increase in the reactions to the vaccines, so much so that it induced Dr. Griffith of the department of clinical immunology of the Glaxo Wellcome research laboratories to suggest that the vaccine should be withdrawn at the start of 1970. Does this not give to the same level of potential concern?

In 1973 the Eastern Health Board records show that the official in charge of the administration of the vaccine within that region was inundated with reports of severe reactions among children. She wrote to Glaxo Wellcome to express concern and the company replied it had no indications whatsoever as to the reason for these, yet three years earlier Dr. Griffith had raised them. The pertussis or whooping cough element of the three-in-one vaccine is widely believed to have been responsible for the adverse reactions and the Eastern Health Board asked Glaxo Wellcome about the possibility of reducing or altering this element. The board was extremely concerned because a number of lots were causing reactions with greater frequency. This gave rise to further cause for concern.

By 1974 in Ireland, the extent of the reactions to the three-in-one vaccine was such that more than 50% of parents were opting not to choose it but the two-in-one vaccine, omitting the pertussis cover. The Government and the Department of Health and Children spokespersons have consistently played down the reports of the reaction to the vaccine but it is privately acknowledged, both in the Department and among GPs, that a lack of a structured reporting regime was preventing them from getting the full picture at that time.

Since 1977, when the expert medical group was established, there has been at least 32 severe reactions to Trivax vaccine, in nine of which the outcome remains unknown. Why have these cases not been investigated in a similar manner to batch 3741? I reiterate my call that the only way this issue can be properly dealt with is through a public inquiry. Those involved deserve answers and the truth behind this scandal. I also call on the Minister to take similar action to that taken to date in relation to the batch 3741 children, to get the information from the Glaxo Wellcome Foundation and to release it to the public.

Minister for Health and Children (Mr. Martin)

I am pleased to have the opportunity to explain the efforts made by my Department to obtain information on the usage of certain batches of Trivax vaccine in Ireland. I thank the Deputy for raising the issue and pay tribute to him for the persistent manner in which he has raised such issues over many years on behalf of a number of families and parents across the country. The background to this issue is that following the Supreme Court judgment in the Best case in 1992, efforts were made to establish the extent to which other persons might also have received vaccine from the batch concerned. From time to time my Department has been approached on behalf of a number of individuals whose families believe 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.

In 1993 my Department wrote to the manufacturer and the health boards requesting information on the usage of vaccine from the batch concerned, No. 3741, but it was not possible to establish the extent of the distribution of the batch. Following extensive searches, the health boards did not trace in any immunisation records continuing references to batch 3741. At that time the number of lots which had been produced from batch 3741 were not available from the Department and it was not realised that the lot numbers were the key to ascertaining what usage was documented.

After further consider in 1997 the Department asked Glaxo Wellcome whether the vaccine may have been identified by lot rather than batch number. Information in response to this inquiry, and indicating the lot numbers of vaccine produced from batch 3741, was obtained from the manufacturer in 1997 and 1998. With the information concerned, it was possible to ask the health boards to examine their records again to see whether there was information available on the usage of vaccine from the batch concerned. After extensive efforts by the health boards, four boards found records which documented 296 cases of persons who received vaccine from batch 3741. It would appear reasonable, however, to assume that vaccine from the batch concerned was administered more widely than in the cases documented in the records traced.

The report which I published on 27 February sets out in detail the information which has been obtained and I have asked the health boards to endeavour to contact the individuals concerned to inform them that they received this product. I understand the four health boards concerned are at present making arrangements to trace the persons involved.

The Deputy referred to other vaccine lots which he considers should also have been followed up in the same manner. In the House on 4 February 1999 he referred to another batch which, he said, had failed the toxicity test, and to some 14 other batches manufactured over a 12 month period from May 1968 and which, he said, were not subjected to this toxicity test. Subsequent to this, on 12 February 1999, the Department wrote again to Glaxo Wellcome seeking information on the issues raised. The company was asked to indicate, if possible, whether vaccine from these batches might have been distributed in Ireland and, if so, whether the relevant lot numbers were available.

The company's response of 12 March 1999 indicated 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. It added that the results of all tests, mandatory and otherwise, together with the expert advice which it had sought, indicated that no other batch gave rise to the same level of potential concern as batch 3741.

The Deputy again raised issues regarding other batches of Trivax vaccine in the House on 19 May 1999 and the Department wrote to the company about these also. The company's final response, received in September 1999, was to the effect that it had made every effort to provide as much information as possible to the Department in response to queries regarding the Trivax vaccine. The Deputy has been provided with copies of this correspondence under the terms of the Freedom of Information Act. He will, therefore, appreciate that this matter has already been pursued by my Department. Extensive international research has been conducted over many years regarding the possible link between the pertussis component of the DTP vaccine and chronic brain damage and that such a link has not been proven. The consensus of the international literature on this subject is that wholecell pertussis vaccine has not been proven to be a cause of brain damage.

By publishing the report I have set out clearly and comprehensively all of the information obtained by my Department about the issues involved. I and my officials are willing to meet the Deputy to further consider these issues and to provide whatever assistance I can on the matter.