Maureen O'Sullivan (Dublin Central, Independent)
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63. To ask the Minister for Health if he is satisfied that the human papilloma virus Gardasil vaccine is totally safe; and his views that in light of concerns raised by parents and concerned parties over the possible health effects of the vaccine that there should be an information guide and consent form sent to parents so they can make an informed decision if they wish their children to be vaccinated [27694/15]

Leo Varadkar (Dublin West, Fine Gael)
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Immunisation is regarded as one of the safest and most cost-effective of health care interventions. International studies and scientific assessments suggest that the best way to prevent most disease due to human papilloma virus (HPV) is to vaccinate as many girls and women as possible. The HPV vaccine protects girls from developing cervical cancer when they are adults. It is available free of charge from the HSE for all girls in 1st year of secondary school. This is in accordance with the recommendation received from the National Immunisation Advisory Committee (NIAC) which indicated that the HPV vaccine should be offered on an annual basis to all girls aged 12. The advice, based on public health considerations and supported by the cost-effectiveness analysis, is that HPV vaccines confer maximum benefit both individually and on a population basis if administered prior to HPV exposure.

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 following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA). With this authorisation, the vaccine can be marketed in all EU Member States. Since first authorisation the HPRA has continuously monitored the safety of Gardasil®. This monitoring includes a review of global safety data in addition to national experience with use of the vaccine. The EMA is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.

While no medicine (including vaccines) is entirely without risk, the safety profile of Gardasil® has been continuously monitored since it was first authorised both nationally and at EU level. This is done by both monitoring of individual adverse reaction reports received by competent authorities across Europe (including the HPRA) and Periodic Safety Update Reports (PSURs) submitted by the Marketing Authorisation Holder (i.e. license holder) for the vaccine on a regular basis. The most recent EU review of cumulative global safety update data completed in December 2014 concluded that the benefit/risk profile for Gardasil® remains positive and concluded that no updates to the product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)) were considered necessary.

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.

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.

The HSE delivers the HPV vaccination programme and provides written information to pupils receiving HPV immunisation and to their parents. The information booklet addresses key questions about HPV, cervical cancer and HPV vaccine, its efficacy, safety and possible side effects. This information can also be found at www.hpv.ie.

Robert Troy (Longford-Westmeath, Fianna Fail)
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64. To ask the Minister for Health if he will meet with a support group that has been established for the parents of children who have suffered serious health complications following the administering of the human papilloma virus vaccination; and if he will make a statement on the matter. [27722/15]

Leo Varadkar (Dublin West, Fine Gael)
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Immunisation is regarded as one of the safest and most cost-effective of health care interventions. International studies and scientific assessments suggest that the best way to prevent most disease due to human papilloma virus (HPV) is to vaccinate as many girls and women as possible. The HPV vaccine protects girls from developing cervical cancer when they are adults. It is available free of charge from the HSE for all girls in 1st year of secondary school. This is in accordance with the recommendation received from the National Immunisation Advisory Committee (NIAC) which indicated that the HPV vaccine should be offered on an annual basis to all girls aged 12. The advice, based on public health considerations and supported by the cost-effectiveness analysis, is that HPV vaccines confer maximum benefit both individually and on a population basis if administered prior to HPV exposure.

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 following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA). With this authorisation, the vaccine can be marketed in all EU Member States. Since first authorisation the HPRA has continuously monitored the safety of Gardasil® . This monitoring includes a review of global safety data in addition to national experience with use of the vaccine. The EMA is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.

While no medicine (including vaccines) is entirely without risk, the safety profile of Gardasil® has been continuously monitored since it was first authorised both nationally and at EU level. This is done by both monitoring of individual adverse reaction reports received by competent authorities across Europe (including the HPRA) and Periodic Safety Update Reports (PSURs) submitted by the Marketing Authorisation Holder (i.e. license holder) for the vaccine on a regular basis. The most recent EU review of cumulative global safety update data completed in December 2014 concluded that the benefit/risk profile for Gardasil® remains positive and concluded that no updates to the product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)) were considered necessary.

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.

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.

The HSE delivers the HPV vaccination programme and provides written information to pupils receiving HPV immunisation and to their parents. The information booklet addresses key questions about HPV, cervical cancer and HPV vaccine, its efficacy, safety and possible side effects. This information can also be found at www.hpv.ie.

As Minister for Health I consider meeting any organisation in the health area that requests to do so. However due to scheduling commitments I am not always available to meet all who request a meeting.