Regina Doherty (Meath East, Fine Gael)
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Question 624: To ask the Minister for Health if the Health Service Executive has investigated claims regarding adverse reactions in young females to the Gardasil vaccine. [27450/11]

James Reilly (Dublin North, Fine Gael)
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The Irish Medicines Board (IMB) has responsibility for investigation of adverse reactions to medicines. Since the first authorisation of Gardasil, the Irish Medicines Board (IMB) has continuously monitored its safety. This monitoring includes review of global safety data in addition to national experience with use of Gardasil. Continuous monitoring of medicines and vaccines involves evaluation of potential safety issues in relation to reported adverse reactions and from all other sources including periodic safety update reports, clinical trials, published literature, epidemiological and non-clinical studies conducted anywhere in the world. This monitoring by the IMB adheres to the relevant European guidance and legislation, Directive 2001/83/EC, Regulation (EC) 726/2004, Volume 9A of the Rules Governing Medicinal Products in the EU and European Medicines Agency (EMA) guidance on the Conduct of Pharmacovigilance for Vaccine.

The IMB has received a total of 458 reports of adverse events associated with use of Gardasil up to 30 September 2011. The majority of the reports have been consistent with the expected pattern of adverse effects for the vaccine, as described in the product information and include cases of malaise, headache, dizziness, syncope (fainting), fatigue, skin and injection site reactions and gastrointestinal symptoms. Anaphylaxis is a very rare known adverse event following immunisation (AEFI) which can occur following any immunisation. The adverse events observed are within the acceptable limits for AEFI as outlined in the Gardasil Summary of Product Characteristics. The EMA in conjunction with its European partners including the IMB recently reviewed Gardasil and has confirmed that there are no safety concerns regarding the vaccine.