Dáil Éireann debate -
Tuesday, 16 Jun 1998

Vol. 492 No. 4

Written Answers. - Vaccination Programme.

Theresa Ahearn

Question:

21 Mrs. T. Ahearn asked the Minister for Health and Children the reason a number of young children had adverse reactions to the two in one vaccine for diphtheria and tetanus, vaccine batch number E6015D; the number of children who had an adverse reaction; the number who required hospitalisation; the nature of the adverse reaction suffered; whether any of the children affected have suffered permanent damage or injury; the action, if any, taken by the Irish Medicines Board and his Department with regard to the batch concerned; and if he will ensure that no further difficulties arise from another batch of the two in one vaccine. [14116/98]

Alan Shatter

Question:

36 Mr. Shatter asked the Minister for Health and Children the reason a number of young children had adverse reactions to the two in one vaccine for diphtheria and tetanus, vaccine batch number E6015D; the number of children who had an adverse reaction; the number who required hospitalisation; the nature of the adverse reaction suffered; whether any of the children affected have suffered permanent damage or injury; the action, if any, taken by the Irish Medicines Board and his Department with regard to the batch concerned; and if he will ensure that no further difficulties arise from another batch of the two in one vaccine. [14115/98]

Paul Bradford

Question:

45 Mr. Bradford asked the Minister for Health and Children the reason a number of young children had adverse reactions to the two in one vaccine for diphtheria and tetanus, vaccine batch number E6015D; the number of children who had an adverse reaction; the number who required hospitalisation; the nature of the adverse reaction suffered; whether any of the children affected have suffered permanent damage or injury; the action, if any, taken by the Irish Medicines Board and his Department with regard to the batch concerned; and if he will ensure that no further difficulties arise from another batch of the two in one vaccine. [14117/98]

Minister for Health and Children (Mr. Cowen)

I propose to take Questions Nos. 21, 36 and 45 together.

It is recognised that adverse reactions to vaccinations such as those referred to by the Deputies, while uncommon, are not entirely unexpected. In common with most vaccines, following administration, some reactions may occur including local reactions consisting of swelling, redness and tenderness at the site of the injection and these may occasionally be serious. The reported reactions to the "two in one" vaccine batch number 6015D were within the scope of recognised possible adverse reactions.

At this time I am advised that the reported suspected adverse reactions associated with the use of this batch of the vaccine involved a total of 15 children and that three children required hospitalisation. All the reports involved local — injection site — reactions and all the children are reported to have made a complete recovery. None of the children is reported to have suffered any permanent damage or injury.

The reports of adverse reactions to this vaccine have been closely monitored by the Irish Medicines Board, in conjunction with its appropriate expert advisory committee. In addition the board consulted with the manufacturer of the vaccine, with the respective health boards and with its counterpart in the United Kingdom, the Medicines Control Agency. The board has also kept my Department fully appraised of the situation. I am advised that following the severe reactions referred to, the health boards suspended further use of vaccines from the particular batch.

The board, as part of its statutory function will continue to monitor any reports of adverse reactions to this or, indeed, any vaccine or medicine so as to ensure the highest standards of public health and safety as are possible. However, as I stated already, it is recognised that occurrences of some adverse reactions, whilst being uncommon, are inevitable and cannot be entirely eliminated.

Many scientific studies have been carried out internationally which show that the advantages of vaccination far outweigh any risks which may be present. All vaccines are extensively tested for safety and efficacy before they are licensed and they are then kept under continual surveillance. I would therefore like to take this opportunity to urge parents to continue to have their children immunised. The risks to their children if they are not immunised are very real. Immunisation is extremely important, it is safe and effective; it is available conveniently from the family doctor and it is free of charge. If sufficient numbers of children are immunised it should be possible ultimately to achieve the eradication of a range of dangerous childhood diseases.