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Vaccination Programme.

Dáil Éireann Debate, Wednesday - 29 September 2004

Wednesday, 29 September 2004

Questions (609, 610, 611)

Denis Naughten

Question:

789 Mr. Naughten asked the Minister for Health and Children further to Parliamentary Question No. 313 of 29 June 2004, the progress to date on the issue; if a detailed examination of the schemes has taken place; the reason for the delay in performing this examination; and if he will make a statement on the matter. [21630/04]

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Written answers

A preliminary review of the vaccine damage compensation schemes in place in a number of other countries was undertaken by my Department. This review was done in order to establish general details of schemes already in existence. It is intended to commence a detailed examination of such schemes before the end of this year.

Denis Naughten

Question:

790 Mr. Naughten asked the Minister for Health and Children the average reported incidence of adverse reactions to each publicly funded vaccination programme; the average incidence of severe adverse reactions to each vaccine; if each of these figures validates the international norm; the numbers of each vaccine administered each year; and if he will make a statement on the matter. [21631/04]

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The Irish Medicines Board has advised that much of the data requested by the Deputy needs to be manually prepared because of the concurrent administration of more than one vaccine under the primary childhood immunisation programme.

It has not been possible to complete this task for all the products in the time available. The information will therefore be forwarded to the Deputy as soon as it is received.

Denis Naughten

Question:

791 Mr. Naughten asked the Minister for Health and Children the number of reported severe adverse reactions to DTP three in one vaccine, since it was first administered through the public health service; the number of reports in each respective year; and if he will make a statement on the matter. [21632/04]

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The Irish Medicines Board, IMB, has received a total of 324 suspected adverse drug reaction, ADR, reports associated with the use of DTP vaccines since 1972, 87 of which are classified as serious in accordance with agreed international criteria.

A serious ADR is defined as one that is fatal, life threatening, results in persistent or significant disability/incapacity, or prolongs hospitalisation. This definition also includes serious adverse clinical consequences. Accordingly, some of the cases listed below are classified as serious because the children concerned were admitted to hospital for observation, or received treatment, which is classified as an intervention. The serious ADR reports received are consistent with those known to occur with the use of DTP vaccines.

The breakdown of these reports for the respective years is as follows:

Year

Cases

1973

1 case

1974

1 case

1975

2 cases

1976

1 case

1980

2 cases

1981

1 case

1982

2 cases

1984

2 cases

1985

1 case

1986

2 cases

1987

1 case

1988

3 cases

1991

3 cases

1992

4 cases

1993

1 case

1994

2 cases

1995

7 cases

1996

8 cases

1997

3 cases

1998

3 cases

1999

2 cases

2000

1 case

2001

3 cases

Since 2001, there is increasing use of combined vaccines, for example, Tetravac, Infanrix IPV Hib, Pentavac etc., which have replaced the DTP vaccines.

As the Deputy did not specify a particular brand of DTP vaccine, the IMB, when collating this information, included all ADRs for all DTP vaccines. Therefore, the total number of ADRs is different than that given in response to previous parliamentary questions, as those questions related to the use of one specific vaccine brand, for example, the question on Trivax answered on 18 October 2000.

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