Michael Fitzmaurice (Roscommon-Galway, Independent)
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475. To ask the Minister for Health if there are any ongoing studies here to examine any adverse reaction to the Gardasil vaccination, not just directly after the injections but for at least five years afterwards; his plans to implement a strategy in this regard; and if he will make a statement on the matter. [29795/16]

Clare Daly (Dublin Fingal, Independent)
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493. To ask the Minister for Health the number of longitudinal studies of girls vaccinated against HPV in the past five years that have been performed and their results. [29876/16]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 475 and 493 together.

In the past ten years the safety of the HPV vaccine has been reviewed frequently by many international bodies including the European Medicines Agency (EMA), the Global Advisory Committee on Vaccine Safety of the World Health Organisation and the Centres for Disease Control and Prevention in the US. These Committees have continually concluded that the vaccine is safe.

The Global Advisory Committee on Vaccine Safety of the World Health Organisation has systematically investigated safety concerns raised about HPV vaccines and has issued several reports in this regard. In December 2015, WHO reported that, it has not found any safety issue that would alter its recommendations for the use of the vaccine. In January 2016 the EU endorsed the use of HPV vaccines in all countries in the EU. This was following a European Medicines Agency (EMA) report on a review of HPV vaccine.

There have been numerous studies published in the past 5 years on the HPV vaccine which have observed those girls vaccinated with the HPV vaccine since it was licensed in 2006. The findings of almost 30 of these studies that I am aware of can be summarised as follows:

- HPV vaccines are highly efficacious (>90%) at preventing infection with targeted HPV types (types 16 and 18 and for the quadrivalent vaccine also types 6 and 11) and related cervical intraepithelial neoplasia. The quadrivalent vaccine has proven efficacy and against HPV16/18/6/11 related vulvar, vaginal, and anal intraepithelial neoplasia and genital warts.

- The vaccines have some, although lower levels of, cross-protection against related type HPV31. The bivalent vaccine also has some cross-protection against types 33, 45, 51 and 52. The bivalent vaccine produces higher antibody titers than the quadrivalent vaccine.

- Following three doses, antibody tirtres plateau by 48 months but are then sustained (bivalent>quadrivalent) for more than 9 years, with no indication of waning protection.

- Two doses of vaccine spaced six months or more apart are as immunogenic in females aged under 15 years as three doses in older women.

- Following population-based vaccination programs, significant declines in genital warts, HPV infection and cervical intraepithelial neoplasia have been observed.

- Herd protection of males against genital warts has been observed following female HPV vaccination programs.

- With over 230 million doses distributed globally, HPV vaccines have been repeatedly assessed as safe. The vaccines are not associated with any increased risk of disease including autoimmune, neurological or thromboembolic disease.

I can provide Deputies with detailed references of these studies.

Worldwide there is no scientific evidence that HPV vaccines cause any long term illness. The Health Products Regulatory Authority (HPRA), the authority regulating the HPV vaccine has never advised that there is any concern about the safety of the HPV vaccine. The HPRA continues to monitor each vaccine and medicine during the life time of its license.

Michael Fitzmaurice (Roscommon-Galway, Independent)
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477. To ask the Minister for Health the number of complaints that have been received each year from 2011 to 2016 by the national immunisation advisory committee, NIAC; the number of complaints received regarding the symptoms as described by the girls who made the complaints, in tabular form; and if he will make a statement on the matter. [29797/16]

Michael Fitzmaurice (Roscommon-Galway, Independent)
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478. To ask the Minister for Health the principal role of the national immunisation advisory committee, NIAC, and the cost of this body in each of the years 2011 to 2015. [29798/16]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 477 and 478 together.

In Ireland, the Health Products Regulatory Authority (HPRA) is the statutory regulatory authority for medicines in Ireland. This is achieved by both monitoring of individual adverse reaction reports received by competent authorities across Europe (including the HPRA) and Periodic Safety Update Reports submitted by the Marketing Authorisation Holder (i.e. license holder) for the vaccine on a regular basis. 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. From the time of authorisation and up to 30th September 2016, the HPRA had received 1063 reports of adverse reactions and events associated with use of Gardasil. This level of reporting for Gardasil reflects the very positive response to calls from the HPRA for reporting of national experience associated with use of the vaccine, following its introduction into the national immunisation programme which commenced in May 2010.

The majority of reports received by the HPRA have been consistent with the expected pattern of adverse effects for the vaccines, as described in the product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)). Vaccination related events, occurring at the time of vaccine administration, such as syncope (faints) has been among the most commonly reported effects. Other commonly reported symptoms include gastrointestinal symptoms, malaise, headache, dizziness and injection site reactions. Reports of allergic-type reactions including skin rashes, urticaria and flushing have also been received, including isolated reports of more severe hypersensitivity-type reactions. There have also been some reports describing persisting/chronic fatigue, generally with multiple other symptoms (e.g. headache, malaise, drowsiness, nausea, gastrointestinal upset, joint swelling, flu like illness, menstrual disorders) following vaccination. The HPRA has informed me that a tabulated listing of case reports will be provided separately to the Deputy.

The National Immunisation Advisory Committee (NIAC) has no statutory role in the monitoring of adverse reaction to licensed medicinal products. NIAC was established within the Royal College of Physicians of Ireland in 1998. It comprises representatives from a broad range of medical and healthcare organisations. The role of NIAC is to provide expert, evidence-based, impartial guidance to the Chief Medical Officer in the Department of Health in the area of immunisation procedures and related matters. NIAC also prepares, and regularly updates, the Immunisation Guidelines for Ireland with the assistance of an active committee from associated disciplines in Paediatrics, Infectious Diseases, General Practice and Public Health. My Department does not provide any direct funding for the Committee.