Clare Daly (Dublin Fingal, Independent)
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1275. To ask the Minister for Health his plans to conduct an independent review of the Gardasil HPV vaccine. [25551/16]

John Brassil (Kerry, Fianna Fail)
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1314. To ask the Minister for Health if he will request the HSE provide a full and complete information leaflet outlining all possible side effects of Gardasil as per the manufacturers leaflet through the schools to parents of teenage girls due to be vaccinated against HPV; and if he will make a statement on the matter. [25698/16]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 1275 and 1314 together.

The HPV vaccine, Gardasil which was introduced in 2010, protects girls from developing cervical cancer when they are adults. It is available free of charge from the HSE for all girls in the first year of secondary school.

Each year in Ireland around 300 women are diagnosed with cervical cancer. The HPV vaccine protects against two high risk types of HPV (16 & 18) that cause 73% of all cervical cancers. Vaccinated women and girls will still be at risk from other high risk types of HPV that can cause cervical cancer and will therefore need to continue to have regular cervical smear tests. The Health Products Regulatory Authority (HPRA) is the regulatory authority for medicines in Ireland. There are two licensed HPV vaccines available in Ireland (Gardasil and Cervarix). Gardasil is the vaccine used by the HSE in the School Immunisation Programme and over 100,000 girls have received this vaccine since its introduction.

The HSE provides information for parents about diseases, the vaccines to prevent them and side effects to allow them to choose whether or not to give consent to vaccination. All vaccination information provided to parents is prepared from the available licensed documentation for each vaccine, the Summary of Products Characteristics and Patient Information Leaflet. The information booklets include information on the most common adverse events that can occur after each vaccination. Seizures, muscle weakness, leg pain, joint pain and chronic fatigue are not mentioned as known side effects to Gardasil in the Patient Information Leaflet. There are no known long term side effects to the vaccine Gardasil. The information is presented in clear simple language and approved by the National Adult Literacy Agency so that it can be understood by all adults as the average reading age in Ireland is 12 years of age. Parents are also given contact details for their local immunisation office and advised to speak to a member of the school immunisation team if they have any further questions.

Should parents require additional information about vaccines the immunisation leaflet refers to the HSE’s national immunisation website (www.immunisation.ie). The national immunisation website has been accredited by the World Health Organisation for credibility, content and good information practices. The website allows members of the public to contact the National Immunisation Office to ask a question if they require further information. These questions, when possible, are answered by the staff of the National Immunisation Office within one working day.

No medicine, including vaccines, is entirely without risk, there is therefore on-going pharmacovigilance and monitoring of medicinal products once they are authorised for use. The safety profile of Gardasil has been continuously monitored since it was first authorised. As part of its monitoring of the safety of medicines, the HPRA operates an adverse reaction reporting system, where healthcare professionals and patients are encouraged to report adverse reactions they consider may be associated with their treatment, through the range of options in place for reporting. All reports received are evaluated and considered in the context of the safety profile of the product concerned, with reports followed up as necessary for further information, that may assist in the assessment of the case.

In November 2015 the European Medicines Agency completed a detailed scientific review of the HPV vaccine. The review, in which the HPRA participated, found no evidence of a causal link between the vaccine and the two conditions examined. The review recognised that, at that time, more than 80 million girls and women worldwide have now received these vaccines, and in some European countries they have been given to 90% of the age group recommended for vaccination. Use of these vaccines is expected to prevent many cases of cervical cancer (cancer of the neck of the womb, which is responsible for over 20,000 deaths in Europe each year) and various other cancers and conditions caused by HPV. The benefits of HPV vaccines therefore continue to outweigh the known side effects. The safety of these vaccines, as with all medicines, will continue to be carefully monitored and will take into account any future new evidence of side effects that becomes available. On 12 January 2016 the European Commission endorsed the conclusion of the European Medicines Agency stating that there is no need to change the way HPV vaccines are used or to amend the product information. This final outcome by the Commission is now binding in all member states.

My Department has no plans to conduct another review.