Dáil Éireann debate -
Thursday, 4 Feb 1999

Vol. 499 No. 5

Adjournment Debate. - Immunisation Programme.

Mr. Naughten

I thank the Chair for giving me the opportunity to raise this issue and the Minister for being in the House.

Three-in-one vaccine doses were administered in the late 1960s and early 1970s and there was an upsurge in the number of severe reactions in children who received them. Since first raising this issue, I have been inundated with queries from parents of children who received the vaccine and were subsequently brain damaged. The story is similar in many cases where parents have been unable to access accurate vaccination records from general practitioners or from the relevant health board.

Currently a search is taking place within all health boards to see how many children received the controversial batch number 3741. However, an additional batch also failed the toxicity test and was more potent than 3741. Some 14 other batches manufactured over a 12-month period from May 1968 were never subjected to this toxicity test. These batches began with the number 3753 and ended with the number 3797. There are serious questions which must be answered by the Wellcome Foundation, now Glaxo Wellcome, and the Department of Health and Children.

The hepatitis C disaster has reinforced the view that the State was obliged in relation to the administration of blood to ensure that it was free from contamination. A similar obligation prevails in relation to the degree of care which must be adhered to in administering three-in-one vaccinations.

In 1973, 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 Wellcome to express concern and the company replied that it had no indications whatsoever as to the reasons for these. However, three years earlier, in 1970, a senior scientist in Wellcome had warned in a memo to senior colleagues that if further reports of severe reactions to the vaccine were received, it might be desirable to cease its manufacture.

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 Wellcome about the possibility of reducing or altering the pertussis element of the vaccine. By 1974 in Ireland, the extent of the reactions to the three-in-one vaccine was such that more than 50 per cent of parents were opting not to have it and chose two-in-one instead, omitting the pertussis cover.

The Government and Department of Health and Children spokespersons have consistently played down reports of reactions to the vaccine, but it was privately acknowledged both in the Department and among GPs that the lack of a structured reporting regime was preventing them from getting a full picture.

In private correspondence to parents of brain damaged children in 1982, Deputy Woods, then Minister for Health, admitted that side effects, such as mental retardation, paralysis, collapse and convulsions were generally recognised as occurring occasionally following whooping cough vaccination. Yet, when the expert medical group concluded in 1982 that brain damage sustained by 14 of the 54 Irish children examined had in all probability resulted from the three-in-one vaccine, the Fianna Fáil Government pursued a policy of trying to buy off the parents by offering them once-off ex gratia payments of £10,000. This was despite strong advice from senior officials in the Department of Health and Children who urged at an early stage following the expert group's initial findings that it would be inconsist ent and inconclusive not to concede proper compensation. However, a small number of cash strapped parents of handicapped children took the paltry offer of £10,000. The Best family did not take this offer.

At the conclusion of the case in the High Court Mr. Justice Liam Hamilton described Wellcome as negligent and criticised the company's quality control procedures. As the Department purchased these products from the Wellcome Foundation, it should be in a position to trace the offending batches and where they were administered. There are serious questions which must be answered and only an independent public inquiry can get to the truth of what became a nightmare for some of those who received three-in-one vaccination. I urge the Minister to investigate these allegations fully and come up with answers to the serious questions.

Minister for Health and Children (Mr. Cowen)

I assume the Deputy is referring to an alleged link between the whooping cough component of the three-in-one vaccine and the occurrence of brain damage in children. It may be helpful to outline briefly the developments on this issue in Ireland since the 1970s. In response to concerns which had been expressed, the expert medical group on whooping cough vaccination was established in 1977 by the then Minister for Health to examine persons who, it was claimed, had been permanently damaged by whooping cough vaccination, to review the medical information available in relation to them and to indicate whether, in its opinion, the damage was attributable to the vaccination. The group was completely independent of the Department of Health in assessing cases. At the outset, it recognised that it would be impossible to prove conclusively in any case whether a person had been damaged by the whooping cough vaccine. Consequently, the group came to its conclusions on the balance of probability in individual cases. Where there was a reasonable doubt in any case, the group gave the benefit of the doubt to that person. The group found that in 16 of the 93 cases which were presented to the group, there was a reasonable probability that the vaccine was responsible for damage. An ex-gratia payment was offered in each of these 16 cases.

In 1992 the Supreme Court found in favour of Kenneth Best, whom it had been alleged had suffered brain damage as a result of receiving DTP – diphtheria/tetanus/pertussis – vaccine. The central issue in the Supreme Court case was the toxicity of a particular vaccine batch involved, namely, batch No. 3741, and the Supreme Court held that the pharmaceutical company, Wellcome, was liable for Kenneth Best's brain damage. The vaccine batch in question was produced in the summer of 1968 and had a two-year shelf life.

Following the judgment in the Best case the Department wrote to the health boards in 1993 in an effort to ascertain the extent to which vaccine from batch 3741 had been used in Ireland. The boards did not succeed in tracing information in this regard. Following receipt of additional information from Glaxo Wellcome in 1997 and 1998 regarding the lot numbers of the vaccine produced from batch 3741, my Department wrote to the health boards to ask them to examine their records to see if the extent of usage of these lots in Ireland in the period 1968-70 could be established. Final responses have been received from seven of the eight health boards. These indicate that in many cases immunisation records for the period in question are no longer in existence. Those which do exist do not always contain the lot number of the vaccine used, as it was not routine practice to record this information at that time.

The health boards' responses to date show that the use of vaccine from some of the lots in question was recorded in 243 cases. The boards in whose areas such usage was recorded are the Mid-Western Health Board, the Southern Health Board and the Western Health Board. My Department is currently considering the health boards' responses with a view to determining what, if any, further action is appropriate in the matter.

On the general issue of adverse reaction to immunisations, it is recognised that, in common with all vaccines and therapeutic substances, there is a small risk of such reactions occurring. The identification and use of contraindications to vaccine has helped reduce any potential risk. As regards national policy, it is considered that the benefits of immunisation to children far outweigh any potential risk and that immunisation protects them and the community at large from the serious consequences of a range of serious diseases, including diphtheria, tetanus, whooping cough, measles, polio and tuberculosis. This is the view not only of the Department of Health and Children and the medical, paediatric and public health experts, but also international experts and the World Health Organisation.

By way of illustration of the benefits of immunisation, it is noteworthy that in 1955 over 3,400 cases of whooping cough and 39 deaths from the disease were reported in Ireland, whereas in 1997 the number of reported cases was 459, with no deaths. General practitioners contracted to provide immunisations under the primary childhood immunisation scheme are aware of the contraindications to the recommended childhood immunisations and are required to provide parents and guardians with pre-immunisation advice and information.

In relation to concerns regarding alleged vaccine related brain damage, my Department has no evidence which would suggest there is any link between vaccination and the subsequent development of neurological damage. Extensive international research has been conducted over many years regarding the possible link between the pertussis component of the DPT vaccine and chronic brain damage. The consensus in the medical literature is that it is not possible to establish a causal relationship between this vaccine and the development of permanent neurological damage. This view is confirmed in the immunisation guidelines for Ireland, produced in 1996 by the Royal College of Physicians, which advises that "although there has been controversy about pertussis vaccine the consensus from authoritative bodies is that it is a safe vaccine".

I am concerned that compared to other European countries we have a high incidence of vaccine-preventable disease. This is despite the fact that we have a free primary childhood immunisation programme which is both safe and effective in preventing these serious diseases. I am also concerned that our immunisation programme is being affected by the ongoing adverse publicity about an issue which first arose many years ago and which has long been resolved as far as other countries are concerned. I would therefore again stress the safety and effectiveness of modern vaccines and urge parents to ensure they have their children immunised so as to protect them against a range of potentially serious yet preventable childhood diseases.