Bernard Durkan (Kildare North, Fine Gael)
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Question 202: To ask the Minister for Health and Children if she has carried out any studies into any possible side effects or reactions in children in the aftermath of three in one or five in one inoculation combinations; and if she will make a statement on the matter. [39693/09]

Mary Harney (Dublin Mid West, Independent)
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The Irish Medicines Board (IMB) is responsible for monitoring national and international emerging evidence about vaccine safety. All medicines and vaccines that are authorized for use in Ireland must first be tested in clinical trials. The products are only authorised if they are deemed to be of acceptable quality, safety and efficacy. The benefits must always outweigh the risks before the any product is authorized for use.

One Diphtheria, Tetanus and Pertussis vaccine (Boostrix) is currently authorised and marketed for use in Ireland. Boostrix is authorised in Ireland (and in many EU member states) through the mutual recognition procedure since 2001. Some of the known side effects with Boostrix are as follows: somnolence (drowsiness), irritability, diarrhoea, vomiting, anorexia, pyrexia (fever > 37.5°C), injection site reactions (such as redness and/or swelling), and injection site pain.

Two 5:1 vaccines are authorised for use in Ireland: Pentavac and Infanrix Penta. Infanrix Penta is licensed through the centralised system which means the same licence applies in all 27 member states. Some of the known side effects with Infanrix Penta are as follows: somnolence (drowsiness), cough, diarrhoea, vomiting, dermatitis, rash, urticaria, lost appetite lost, fever = 38°C, local swelling at the injection site (= 50 mm), fatigue, pain, redness. Also, crying abnormal, irritability, restlessness. Full details of the licence is available on the website of the European Medicines Agency, at www.emea.europa.eu. Pentavac is licensed in Ireland and in many EU member states through the mutual recognition procedure since 2001. The side effect profile for Pentavac is as follows: Somnolence, Diarrhoea, Vomiting, Anorexia, Redness, induration at the injection site, Pyrexia, Nervousness (irritability)and abnormal crying.

Detailed product information about all of these vaccines is available on the website of the Irish Medicines Board at www.imb.ie