Maureen O'Sullivan (Dublin Central, Independent)
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Question 82: To ask the Minister for Health and Children if her attention has been drawn to the number of side effects young persons have experienced having received the cervical cancer vaccine; if she has satisfied herself that adequate information on possible side effects is given out with the consent form; her views on the fact that a private company is offering to provide this vaccine in some schools [45685/10]

Mary Harney (Dublin Mid West, Independent)
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There are two vaccines licensed in Ireland to prevent HPV infection. Cervarix was licensed in September 2006 and Gardasil was licensed in September 2007. Both are therefore available privately for use under the direction of a medical practitioner and it is known that one insurer is offering a HPV vaccination service in some schools to girls not covered under the public scheme.

The public HPV immunisation programme commenced earlier this year in schools. It is estimated that up to 45,000 doses of Gardasil have been administered in the programme up to the end of October 2010. Prior to any girl receiving the first dose of Gardasil all parents/guardians receive a fact sheet, consent form and accompanying letter detailing when and where the vaccination will take place and containing a phone number to call if they have any queries. The fact sheet contains information in English and Irish about HPV itself and the vaccine, including possible side effects and contraindications. The contents of this agreed national fact sheet were developed using the guidance of the National Adult Literacy Agency (NALA) to ensure clarity, as well as any feedback from parents whose daughters received the first does of vaccine in May 2010. At the back of the fact sheet parents/guardians are advised that they can read more about HPV vaccine and cervical cancer at www.hpv.ie. This website contains additional information including the Patient Information Leaflet and Summary of Product Characteristics (the licensed information about the vaccine) and also directs parents to the national immunisation website www.immunisation.ie which contains the fact sheet translated into eight other languages as well as further additional information for health professionals. The www.hpv.ie website also allows parents to email any queries they may have and these are responded to by the National Immunisation Office within 24 hours.

The Irish Medicines Board (IMB) received a total of 105 reports of adverse events associated with the use of Gardasil up to 29 November 2010. The reports have been mainly consistent with the expected pattern of adverse effects for the vaccine, as outlined in the product information, and include cases of injection site reactions, malaise, headache, myalgia, fatigue, gastrointestinal symptoms and skin reactions (including urticaria). Vaccination related events such as dizziness and syncope (fainting) were among the most commonly reported reactions. Hypersensitivity reactions were also received including a small number of reports of anaphylactic-type reactions. These cases were investigated and reviewed by the IMB and where appropriate, the National Immunisation Advisory Committee (NIAC). These adverse events are within the acceptable limits as outlined in the Gardasil Summary of Product Characteristics. On the basis of the available evidence, the IMB considers that the benefits of the vaccine exceed its risks and both the IMB and NIAC recommend its continued use. The IMB together with the European Medicines Agency will continue to monitor closely the safety of Gardasil.