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Dáil Éireann debate -
Thursday, 5 Jul 2001

Vol. 540 No. 3

Private Notice Questions. - Administration of Animal Vaccines.

We will now deal with Private Notice Questions to the Minister for Health and Children on vaccines administered to children in the 1970s. I will call on the Deputies who tabled questions to the Minister for Health and Children in the order in which they submitted them to my office.

asked the Minister for Health and Children the progress he has made to date regarding the investigation by his Department into reports of the administration of animal vaccine to children in the early 1970s; and if he will make a statement on the matter.

asked the Minister for Health and Children if he will report back to Dáil Éireann, as promised on 28 June 2001, on the findings of his Department in relation to the revelations that a veterinary vaccine (details supplied) normally administered to cows, was given to Irish children during the 1970s as part of drug trials for a company (details supplied); if he will address the implications of this revelation for childhood vaccination programmes; and if a full public inquiry on the issue is being considered.

asked the Minister for Health and Children the progress to date regarding the investigation announced by him in the House on 28 June 2001 into allegations that in 1973 children may have been administered an animal vaccine (details supplied); and if he will make a statement on the matter.

The Department of Health and Children was not aware of the information contained in a report in the Irish Independent last week which suggested that a veterinary vaccine, tribovax-T, had been administered to an Irish child in 1973.

Following the publication of this report, the Minister instructed the Department of Health and Children to take immediate action and, as a result, an urgent investigation is currently being carried out by the company now concerned, GlaxoSmithKline. The Eastern Regional Health Authority and the Irish Medicines Board have also undertaken inquiries into the matters raised in the article. The Department has had meetings with representatives of each of these organisations in recent days. The Minister informed the House last Thursday that he would await the outcome of inquiries before considering what further action was necessary. He also telephoned senior management of the company to ensure that full co-operation would be forthcoming and he was assured that it would be. While these are early days in the context of the vast amount of documentation involved, the Minister asked for and has received, within the past few days, an initial progress report from GlaxoSmithKline.

Department officials met representatives of GlaxoSmithKline last Friday afternoon and the company was asked to address three areas of concern as a matter of urgency. The three questions were: was a child vaccinated with a Wellcome vet erinary vaccine in the early 1970s and, if so, how did this occur and were any other children affected? Did GlaxoSmithKline investigate any or all of the batches or lots listed in the adverse event schedule provided by the Eastern Health Board and, if so, what were the results of this investigation? Did the alleged administration of a veterinary vaccine to a child occur in the context of a clinical trial or as part of the vaccination programme?

The Department stressed the need for urgent answers to these questions and the company sent an initial report to the Department last Tuesday, 3 July. The company has stressed that its interim report is a focused but limited review of readily available documents with the intention of providing some response as quickly as possible. It does not reflect the results of a fuller search which will take some months to complete. In that context, the company's response is as follows.

In relation to the first question – was a child vaccinated with a veterinary vaccine and, if so, how and were other children involved? – the company has advised that vaccination records for children reporting adverse events relating to DTPw – Diphtheria, Pertussis, Tetanus – for the period in question are held by the Eastern Regional Health Authority. An examination of these records by the Eastern Regional Health Authority has revealed two vaccination records where the batch number of the vaccine, as shown in the hand-written copy of the original vaccination record, is 84796, which is the lot number of the veterinary vaccine, tribovax-T.

The company made the following points in that regard. First, a transcription error is highly possible. Copies of vaccination records for children with adverse events include, among others, records where the lots involved are trivax lots, numbered 84769, 84496 and 84795. Each of these three lot numbers differ from the tribovax lot number – 84796 – by only a single digit or by reversing two similar digits.

Second, another factor which questions the likelihood that tribovax-T was administered to children is the fact that tribovax-T was presented in 20 ml vials containing ten doses of vaccine, each of 2 mls The carton is clearly labelled, "tribovax" Combined Cattle Vaccine. By contrast, trivax was presented in 5 ml vials containing ten doses, each of 0.5 mls It appears unlikely that a nurse or doctor carrying out routine vaccinations in a clinic setting could administer tribovax-T in error, given the difference in appearance of the two presentation forms. Third, the company is also looking into the unlikely possibility that tribovax-T was packed in 5 ml trivax vials, although, in its view, this is unlikely to have happened.

In relation to the second question – did the company investigate any or all of the lots listed in the adverse event schedule provided by the Eastern Health Board and, if so, what were the results of this investigation, the company has advised that in its necessarily limited review over recent days, the only relevant batch analysis records identified as having been sought from and compiled by Wellcome were details of the mentioned batches in terms of when they were manufactured and where they were sent. At this stage, the company states that no conclusion can be drawn on whether the batches were investigated fully without reviewing manufacturing records held in the United Kingdom. Given the volume of records involved, this will take some time, but the company has indicated that it intends to complete this review as expeditiously as possible.

The issue of concern in the third question is whether the adverse events occurred in the context of a clinical trial or as part of the vaccination programme. The company has advised that the names of the children on the schedule listing adverse events recorded at clinics with trivax during 1972-73 have been checked against the listing of children participating in the 1973 trial, which was investigated as part of the Chief Medical Officer's report on vaccine trials that has now been referred to the Laffoy commission, and no names match. While the company reports that it has not uncovered any documentation supporting the existence of a second trial, it has also stated that further investigation is required on this point.

Clearly, in the amount of time available and given the volume of documentation involved, a complete investigation has not been possible. The Minister has been informed that a fuller review by the company will take some months to complete, but that a further report will be submitted to the Department before the end of this month. The Irish Medicines Board has requested information from the Medicines Control Agency on the inspections and standards of good manufacturing practice during the period in question as well as details of any recalls or quality defects relating to trivax or tribovax-T. It will take some time before the requested information from the UK Medicines Control Agency is available, but the Minister has been assured that the results of the IMB's inquiries will be made known as soon as possible.

A further indicator that a transcription error may be involved, as suggested by the company, appears in a copy vaccination record which the ERHA has uncovered. This indicates that, in the case of one of the records, the immunisation with the vaccine allegedly numbered 84796 was stated to be DT and not DTP – trivax. As there are two vaccination records showing the lot number 84796, one for a recipient of DTP – trivax – and the other DT, it appears to cast further doubt on the accuracy of record-keeping at the time.

I stress that this issue is not related to the current immunisation programme and I take this opportunity to reassure parents, health professionals and the public about the safety of current vaccines. All the expert advice available to the Department indicates that the vaccines currently in use in the primary childhood immunisation programme are very safe and they are highly effective in preventing infectious diseases in individuals and the community generally. It is important to note that vaccines are subject to rigorous testing before being licensed and they are also subject to ongoing monitoring when in use. The benefits of immunisation to children far outweigh any potential risks and help to protect them from the serious consequences of previously prevalent diseases such as polio, whooping cough and measles.

Immunisation has been proven to be a very safe and effective measure in combating infectious disease in children and the community generally and has played a major part in the reduction of childhood death and illness from infectious disease. The primary childhood immunisation programme will continue to be an essential element of our health service and I urge all parents to have their children fully immunised. This will ensure that individual children and the population generally have maximum protection against the diseases concerned.

I intend to circulate the initial report to Deputies.

The Minister of State has said that two vaccination records quote the lot number of tribovax-T Does this indicate there are two children involved, and not one as was indicated in media reports last week?

The Minister stated that details of the mentioned batches, in terms of where they were manufactured and where they were sent, have been recorded. Does the Minister believe this to be unusual, given that this is the first time the Wellcome Foundation has admitted it recorded where vaccine batches were sent? In answer to previous Parliamentary Questions, Ministers have stated that the company did not have such records.

What does the Department of Health and Children intend to do about the child or children who were given the veterinary vaccine? Does it intend to contact the children?

Reports in last Friday's newspapers claim that Wellcome withheld information highlighting reactive batches from the Eastern Health Board. What has been the company's response to this report?

What comment has the Irish Medicines Board made regarding the lack of reporting by Wellcome of adverse reactions? This is contrary to a reciprocal arrangement between the NDAB and Wellcome which was in place at the time. Does this not highlight the fact that Wellcome was trying to conceal the extent of adverse reactions to this vaccine? Would it not have damaged the progress of the vaccine trial which was taking place had the NDAB become aware of that fact?

The records of the Eastern Health Board, now the Eastern Regional Health Authority, indicate that two children received the vaccine from the relevant batch No. 84796. These two children have been identified. At the time one child experienced a localised reaction in his arm and vomited for 24 hours. The other child had no reaction. There is no evidence at this stage that other children are involved. However, investigations are continuing. We must await the outcome of the full investigation before proceeding with any action in relation to the children.

The company that was Wellcome is now GlaxoSmithKline, which is a completely new company. It has given every assurance that it is committed to co-operating fully with the investigation and to giving all information at its disposal. It is carrying out a much fuller investigation than has been done to date. The Deputy is aware that the report we have is of an initial investigation.

At the time there were no formal arrangements for reporting adverse reactions. Such reporting is now done as a matter of course. General practitioners now record adverse reactions, report them to the Irish Medicines Board and they are then followed up. There is now much greater accountability than was the case 30 years ago. The IMB is continuing its own much fuller investigation, as is the Eastern Regional Health Authority. When we know the outcome of these investigations and the investigation by GlaxoSmithKline I will inform the Deputies.

Now that it is clear that a record was kept in the Eastern Health Board at the time and that it appears that the children received a veterinary rather than a human vaccine, can the Minister of State tell the House if their parents were informed of this? The children could be the children of Members of this House. Have the parents been advised that their children may have received veterinary vaccine?

Is the Minister satisfied the system of reporting adverse reactions to vaccines is now working satisfactorily? There is an onus on general practitioners to report adverse reactions. Is the Department satisfied that parents are sufficiently informed as to the nature of an adverse reaction? The annual report of the Irish Medicines Board outlined 1,000 cases of adverse reactions for all medicines in one year. The report did not focus on immunisations.

I mentioned that the examination of the records of the Eastern Regional Health Authority had revealed two vaccination records. At the time those vaccines were given it was not known what lot they came from or that there was even any question of the lot not being the appropriate vaccine. The question is still open. At the time there was no question of any irregularity so there would not have been a need for the parents to be told. Even today we cannot confirm that there was an irregularity. Neither can we confirm that there was not. That is why the investigation must continue.

The current structure for reporting of adverse reactions is both formal and statutory. Because it is statutory one hopes it is adhered to. However, it must be kept permanently under review and I accept Deputy McManus's point on that.

Since this controversy arose I have been contacted by parents who have informed me that, in the 1970s, their children exhibited symptoms which tallied with an adverse reaction to a vaccine.

At this stage, is it possible to ask parents to inform us about adverse reactions at that time. It is a long time ago but does the Minister of State see this as a possibility?

Does the Minister of State envisage an independent inquiry or should it be conducted by the Joint Committee on Health and Children? Would that be a proper way to pursue this matter.

It would be premature to follow the procedure outlined by Deputy Gormley. It is important that we await the outcome of the investigations by the company, the Irish Medicines Board and the Eastern Regional Health Authority and look at that information in detail when it is available. I understand the company intends returning to the Department by the end of this month. I will ensure that information is made available to Deputies.

This is still an open story but one about which we are very concerned. We do not have the full information. We only have the initial report and it is important that the investigations be carried out as speedily as possible. The Minister will decide what action to take on foot of the full information.

Is it the intention of the Eastern Regional Health Authority to review the records for the period to see if other children were vaccinated with vaccine from lot No. 84796? Has the ERHA reviewed its documentation, as the purchasing agent in Ireland, to see if the lot was distributed to other health board areas?

Wellcome claims this was a transcription error. Was the transcription error made in the Eastern Health Board or within Wellcome? If it did happen within the Eastern Health Board area, would Wellcome not have sought clarification at that time from the Eastern Health Board? If it was an inaccurate lot number, Wellcome could have traced it. Did that happen? I ask the Minister why the Eastern Health Board did not report the reactions to the NDAB. It is not good enough to say there was no statutory provision in place at that time. Will the Minister clarify that the Eastern Health Board in 1999 claimed that in the period 1972 to 1973, there were 73 cases of adverse reaction within three lots? However on 28 June 2000, it claimed that there was a total of 73 cases in the available records for that period of time. Last week the Irish Independent claimed that there were over 80 reactions between January and June of 1973, a quarter of the period of time involved. Yesterday, the Eastern Regional Health Authority claimed that there are 100 reported reactions from that period which were referred to Wellcome. Who is correct? If the Irish Independent produces an article tomorrow to say that there were 250 cases, will the ERHA come back and say there are even more cases? Who is telling the truth and how many adverse reactions were there in the Eastern Health Board region and why are there no figures from other health board areas?

The Eastern Regional Health Authority has carried out an examination of records and so far any examination has revealed only two people who would have benefited from it.

Is it ongoing?

I wish to allay people's fears. The ERHA is fully investigating all those records which are available to them from that time. The question of who made the mistake at the transcription is being investigated. It is not known at what level or at what source it may have happened. Quite obviously the reporting system of the time was very poor and was so across all the systems of 30 years ago. That is why there has been significant improvement now in reporting adverse reactions. The Irish Medicines Board has a pharmacological unit to promote, collate and analyse all the data and so ensure that the system can be protected.

I ask the Minister to say if it is a fact that Wellcome withheld information regarding reactive batches from the ERHA? Is it not also a fact that Wellcome withheld information from the National Drugs Advisory Board regarding adverse reactions? Is it not also a fact that Wellcome has been slow to divulge information regarding the vaccine used, its administration and its production? Is it not also the case that at least two batches of vaccine produced in the late 1960s were at least 14 times more concentrated than the British standard at that time and that 14 batches were never subjected to the standard toxicity tests at that time? That comes to a total of four million vaccine doses that did not conform to the standard of the time. The Department of Health established the expert medical group and found that in all probability the vaccine contributed to brain damage in the cases of 16 children. The Minister for Health at the time compensated them to the tune of £10,000. Does the Minister agree that it is time to have a full public inquiry to investigate this issue so that the full information in the possession of Wellcome can be made publicly available and so that at long last parents can find out what happened to their children?

All of the questions raised by Deputy Naughten will be part of the investigation. It is important to say that we too are concerned. We only have the initial reports at this stage and a full investigation is taking place in the new company, in the Irish Medicines Board and in the ERHA.

Would the Minister accept that she has not been able to answer directly the questions posed today? When will she be in a position to answer these important questions? When will the investigations be complete so that some truth can emerge and then we can consider the inquiry?

The initial report which I have to hand will be circulated immediately to the Deputies. The company is due to return to the Minister and the Department by the end of this month with a fuller investigation and that information will be made available to the Deputies. The Minister will then decide what action needs to be taken.

That concludes the Private Notice Question.

Written answers follow Adjournment Debate.

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