Dáil Éireann debate -
Tuesday, 9 Oct 2001

Vol. 541 No. 4

Adjournment Debate. - Tribovax T/Trivax Vaccine.

Mr. Naughten

I thank the Ceann Comhairle for giving me the opportunity to raise this matter.

I thank the Minister for Health and Children and his officials for the reply to a parliamentary question of last Wednesday and the reports enclosed therein. However, a number of question marks still hang over the debate. The major one is that on 24 September 1973 Dr. Dunleavy of the Eastern Health Board wrote to Wellcome enclosing a list of lot numbers of Trivax which had caused severe adverse reactions. Included in this report were two lot numbers which corresponded to Tribovax T. It must be noted that this report was compiled at the request of Wellcome so they could investigate the reasons for these severe reactions. Surely the first step performed on receipt of these lot numbers was to check the analytical log books to find the corresponding batch number. At that stage it should have been clearly evident that these two lot numbers corresponded to a Tribovax T and not a Trivax vaccine batch. If this was a transcription error why was the Eastern Health Board not contacted and asked to clarify the error? Why has GlaxoSmithKline not furnished any information in relation to this investigation of these lot numbers in its eight page report? Not a word is mentioned in that report and one must ask why.

Regarding the manufacturing procedures employed in the production of both vaccines it is the case that both vaccines were stored in the same cold store after their arrival in Dartford. Both vaccines were transferred to the filling room at approximately the same time due to the sequential lot numbers allocated to the batch of Trivax and Tribovax T. It is claimed in the GlaxoSmithKline report that the quality control procedures used to check the final product would have made it impossible to mistake the two vaccines. However, in 1991 Wellcome in the Best High Court case openly admitted its quality control procedures at that time were virtually non-existent. How can the company stand over its procedures in 2001 when it was not prepared to do so in a court of law ten years earlier?

It is a fact that three separate medical practitioners in three separate clinics at Rathfarnam, Crumlin and Temple Street Children's Hospital recorded that Tribovax T was administered to children. It is a fact that these children reacted severely to the vaccine and it is a fact that Wellcome received reports of these reactions on 24 September 1973 for the purpose of carrying out an investigation into those reactions. The statistical probability of three separate and eminent medical practitioners in three separate clinics recording in error a Tribovax T batch number instead of a Trivax number, while the Wellcome investigative team failed to pick up on that transcription error, is the same as that of winning the lotto twice in one week.

GlaxoSmithKline had a vested interest in ensuring that this was a transcription error yet the Minister has not provided a shred of evidence to support this claim. I ask him to reply to the following questions in his response. Does he agree that the formal record clearly states that these children were administered with an animal vaccine? Has he any evidence or record that states definitively that this vaccine was not an animal vaccine? Has he in his possession the results and conclusions of the Wellcome investigation into these severe reactions, which would have highlighted the transcription error, if that was the case? Have GlaxoSmithKline, the Eastern Regional Health Authority and the Department of Health and Children a copy of the correspondence that would have been sent by Wellcome to the Eastern Health Board pointing out that these batches were Tribovax T, not Trivax, and that this must have been a mistake?

Does the Minister honestly believe that there was a transcription error and that, if it had been a transcription error, Wellcome would not have raised the matter with the Eastern Health Board in 1973? I suggest to him that, on the basis of all the currently available information, the conclusions drawn by GlaxoSmithKline, the Eastern Regional Health Authority and the Irish Medicines Board are supposition and conjecture. The Minister has not yet provided one scintilla of evidence to support the claim of the company.

Minister for Health and Children (Mr. Martin)

I thank the Deputy for raising this issue and apologise for the mishap last week. I was outside and got here one minute too late. Hence, I was not in the Chamber and my script was outside the door. It has taught me to be present and not to be distracted in the corridor on the way to the Chamber.

I am pleased to have this opportunity to clarify the issue. The background to it is the publication of reports in the Irish Independent on 28 and 29 June last which suggested that the veterinary vaccine Tribovax T was administered in error to Irish children in the early 1970s. Following publication of these reports I instructed my Department to take immediate action and investigations were initiated by the company concerned – now GlaxoSmithKline – the Eastern Regional Health Authority and the Irish Medicines Board.

A preliminary report was received from GlaxoSmithKline on 3 July last and a copy of this report was given to Deputy Naughten. The company's final report was received on 27 September and I have given a copy to Deputies Naughten, McManus and Gormley. The report is available to any Member of the House should they request it. I am also making it available to the media. I will briefly outline its conclusions for the House.

The company's report has put the case that transcription errors in the lot numbers recorded in hand-written vaccination records are a much more probable explanation than the allegation put forward in the Irish Independent that a child had received Tribovax T instead of Trivax. The company argues that lot numbers of Tribovax T and Trivax are very similar, whereby the transposition of only one digit would be sufficient to result in the lot number of the human vaccine Trivax being incorrectly recorded, as if it were the veterinary vaccine Tribovax T manufactured by the same company.

The company's report also sets out in considerable detail the manufacturing process for both Trivax and Tribovax T which, according to the report, were manufactured in separate buildings, then put in cold storage in separate buildings and released from storage into different sized bottles. The company states that the human vaccine Trivax was contained in ten litre, green labelled bottles and subsequently filled into 0.5 millilitre ampoules or five millilitre bottles, whereas Tribovax T was contained in 15 litre red labelled bottles and subsequently filled into 20 millilitre and 100 millilitre bottles.

A Trivax vaccine would have been clearly distinguishable from Tribovax T when received by the health board clinic. In appearance, Trivax was a white precipitate in water white solution, whereas Tribovax T was a heavy precipitate in light brown solution. Furthermore, Trivax was in 0.5 millilitre ampoules and 5 millilitre round clear glass bottles whereas Tribovax T was in 20 millilitre and 100 millilitre square, clear glass bottles according to the report. The outer packaging of the vaccines was also clearly distinguishable. Trivax cartons were labelled "Trivax – Diphtheria, Tetanus and Pertussis Vaccine. Dose 0.5 ml" and the Tribovax T vaccine was labelled "Combined cattle vaccine. Dose 2 ml. For protection against blackleg and black disease." The company's report has concluded that:

. . . given the manufacturing controls and quality checks described above coupled with the physical inspection necessary to complete the mandatory routine testing of filled bottles of Trivax vaccine, it is virtually impossible for Tribovax T to have been passed as Trivax, given the marked physical difference in appearance of the vaccines.

Notwithstanding the fact that the alleged administration of the animal vaccine took place almost 30 years ago and the difficulties this has caused in terms of investigating the issue, the Irish Medicines Board and the Eastern Regional Health Authority consider that, on the basis of all currently available information, the most likely explanation is that the health professionals involved at the time may have made simple hand-written errors in transcribing the lot number from the vaccine to the individual vaccine record cards.

The company, in its report, had indicated that should any further information of relevance come to hand, it would inform my Department immediately. Subsequently, on 4 October, GlaxoSmith-

Kline wrote to my Department to state that it had also checked the lot numbers in all listings of reported adverse events to Trivax received from the Eastern Health Board to see whether all related to this product. Some additional information has come to light as a result of this exercise.

The company has advised that three further discrepancies have been found, in which the batch numbers cited refer to products other than Trivax. Two of these corresponded to distilled water vials and the other to blackleg vaccine products manufactured by the same company. As in the other cases, the transposition of one digit in each instance would give a Trivax batch number corresponding to ones in use in the Eastern Health Board area during the 1970s. The company has stated that it appears that these cases also arise from simple transcription errors. As this information has only come to light in the past few days, I am now seeking further clarification and will keep the Deputy informed.

The Deputy will appreciate that I am most anxious that public concern arising from these allegations should be allayed. Parents should continue to have confidence in the ongoing vaccination programmes and the benefits to children's health of such programmes.