Dáil Éireann díospóireacht -
Wednesday, 7 Mar 2001

Vol. 532 No. 2

Written Answers. - Vaccination Programme.

Bernard Allen

Ceist:

137 Mr. Allen asked the Minister for Health and Children if he will make a statement on the latest Irish Medicines Board statistics which reveal that there have been more than 100 adverse drug reactions, of which 34 have been serious, to the Meningitis C vaccines, as reported in a publication (details supplied) on 2 March 2001. [7023/01]

Bernard Allen

Ceist:

138 Mr. Allen asked the Minister for Health and Children if he will make a statement on the situation where the Irish Medicines Board was unable to provide up to date statistics on reactions to the Meningitis C vaccine, as reported in a publication (details supplied) on 2 March 2001. [7024/01]

Bernard Allen

Ceist:

139 Mr. Allen asked the Minister for Health and Children if he will make a statement on the Irish Medicines Board's recent statistics, which show that 143 children had adverse reactions to the drug used in the Meningitis C vaccine as reported in a publication (details supplied) on 2 March 2001. [7025/01]

Minister for Health and Children (Mr. Martin)

I propose to take Questions Nos. 137 to 139, inclusive, together.

The information concerning adverse reactions to drugs, to which the Deputy refers, was taken from the Irish Medicines Board drug safety newsletter, circulated in December 2000. This edition included an article on the Meningococcal C vaccine, which referred to 143 reports of suspected adverse drug reactions, which had occurred in the same number of children. The majority of these reports were classified as "non-serious" and consisted mainly of local reactions, rashes and fever.

The remaining reports were classified as serious, in accordance with the internationally agreed definition of the term. The majority of the "serious" reports include cases of rashes, fever, syncope, urticaria and hypotensive episodes and were classified as "serious" only because the patients concerned required treatment such as antibiotics, antihistamines or observation in hospital. Two of the reports were cases of menin gococcal B infection, which of course could not be related to the vaccine.

The incidence of adverse reactions is not unexpected and the majority of reactions notified to date are currently reflected in the product information. The reports of reactions in 143 children should be evaluated in light of the estimated use of the product. Approximately 350,000 doses of the vaccine were administered in Ireland during that time period – October to December 2000. It is also important to note that, prior to the launch of the vaccination campaign, the Office for Health Gain actively encouraged the reporting of any suspected adverse reactions to drugs observed with this new vaccine.

The Irish Medicines Board is unaware of any specific incidence where it was unable to provide up to date statistics on adverse reactions. The board has informed me that on receipt of a suspected adverse drug reaction report, the pharmacovigilance and medical staff immediately review, validate and evaluate the report concerned. Frequently, this requires follow-up correspondence with the reporting healthcare professional or pharmaceutical company. The Irish Medicines Board is willing to give updated information at any time but this information can only be released when follow-up and evaluation of the case report has been completed.