Michael Healy-Rae (Kerry South, Independent)
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197. To ask the Minister for Health if there are details on the 873 girls who have been affected by the vaccine against the Human Papilloma Virus; his plans to check and evaluate the effects on those given the vaccine; if the mortality rate for cervical cancer has reduced due to the Gardasil vaccination; and if he will make a statement on the matter. [29345/15]

Leo Varadkar (Dublin West, Fine Gael)
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In Ireland, the Health Products Regulatory Authority (HPRA) is the regulatory authority for medicines in Ireland. Gardasil^®is a medicinal product which has been authorised for use across the European Union since September 2006. While no medicine including vaccines is entirely without risk, the safety profile of Gardasil^®has been continuously monitored.

Up to the 8 June 2015, the Health Products Regulatory Authority (HPRA) has received 873 reports of suspected adverse reactions/events notified in association with Gardasil^®. National monitoring experience has been consistent with the expected pattern of adverse effects known to occur with the vaccine, as outlined in the approved product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)) for Gardasil^®. The majority of the reports received to date involved events/reactions related to injection site reactions, malaise, headache, myalgia, fatigue, gastrointestinal symptoms and skin reactions. Vaccination related events such as dizziness and syncope (fainting) was also reported and would not be unexpected in this patient population.

Healthy Ireland, the Framework for Improved Health and Wellbeing 2013 – 2025, is the national Framework for action to improve the health and well-being of the population of Ireland over the coming generation. Vaccination against HPV types 16 and 18, which protects girls from developing cervical cancer when they are adults, is a long-term investment as the initial costs of vaccination will be offset by improved health outcomes and treatment savings 15 to 30 years in the future.

The HPRA continues to ensure that the quality, safety and efficacy of all vaccinations licensed in Ireland including HPV meet the required standards. The safety profile of Gardasil^®has been continuously monitored since it was first introduced both nationally and at EU level and like all medicines and vaccines will continue to be so.