Dáil Éireann - Volume 521 - 20 June, 2000

Written Answers. - Trivax Vaccine.

177. Mr. Naughten asked the Minister for Health and Children the year in which the licence to sell and administer the Trivax vaccine in Ireland was first granted by the National Drugs Advisory Board, now known as the Irish Medicines Board; the number of reported reactions to the Trivax vaccine in each year during the period in which it was administered in Ireland; the year in which the Trivax vaccine was taken off the Irish market; the reason it was taken off the Irish market; and if he will make a statement on the matter. [17560/00]

Minister for Health and Children (Mr. Martin): Trivax was first granted a product authorisation in 1978 by the Minister for Health, on the recommendation of the National Drugs Advisory Board.

The following suspected adverse reactions to Trivax vaccine were reported to the National Drugs Advisory Board during the period it was in use in Ireland:

Year

Number of cases

Year

Number of cases

1972

3

1984

9

1973

1

1986

7

1976

9

1987

2

1978

1

1989

6

1979

1

1991

6

1980

1

1992

1

1981

9

1993

23

1983

8

1995

33

It is important to recognise that the pharmacovigilance monitoring system may only receive limited information about suspected adverse reactions as it is dependent on the level of information supplied by the health professional making the report and the timeliness with which [1020] the report is submitted. In some instances the reports are made some time after the administration of the product. The making of reports under the system does not establish a causal link between administration of the product and the reported symptoms or illness.

The company voluntarily ceased marketing this product in 1994.