Written answers

Tuesday, 1 December 2009

Department of Health and Children

Vaccination Programme

12:00 pm

Photo of Maureen O'SullivanMaureen O'Sullivan (Dublin Central, Independent)
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Question 145: To ask the Minister for Health and Children if she will comment on reported unusual adverse reactions in Canada to swine flu vaccinations; the withdrawal of doses produced by a company (details supplied); the reported deaths of two persons in Canada from the vaccination; and if she is satisfied with the use of a company in view of their involvement in the two scandals. [44051/09]

Photo of Mary HarneyMary Harney (Dublin Mid West, Independent)
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The adverse reactions in Canada occurred following vaccination with Arepanrix. Arepanrix is an H1N1 vaccine which is not used in Ireland and is currently only available in Canada, where a single batch of vaccine has been quarantined, due to a suspected but unconfirmed increase in reporting of cases of anaphylaxis.

Anaphylaxis is an acute, allergic type response which can involve multiple body systems (cardiovascular, respiratory, skin and mucosal) and may rapidly progress to a severe, life-threatening reaction. It may occur following exposure to allergens from a variety of sources including food, insect bites/stings, as well as medicines and vaccine. The risk of vaccine-induced anaphylaxis is thought to occur at a frequency of between one and ten cases per million doses of vaccine given.

The prescribing information for the H1N1 vaccines warn of this possible risk and the need to ensure that appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event. The Irish Medicines Board continues to advise healthcare professionals to be prepared to treat allergic reactions, including rare cases of anaphylaxis appropriately, when administering any vaccine including both of the H1N1 vaccines in use in Ireland (Celvapan and Pandemrix). For both of these vaccines, the number of reports of anaphylaxis received throughout the EU remains in line with the broadly accepted frequency estimates of vaccine induced anaphylaxis.


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