Written answers

Tuesday, 23 June 2015

Department of Health

Vaccination Programme

Photo of Thomas PringleThomas Pringle (Donegal South West, Independent)
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451. To ask the Minister for Health if he will consider meeting with a support group (details supplied) which includes concerned parents whose children were affected by the human papilloma virus vaccination; and if he will make a statement on the matter. [24866/15]

Photo of Leo VaradkarLeo Varadkar (Dublin West, Fine Gael)
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The immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). NIAC is a committee of the Royal College of Physicians of Ireland comprising of experts in a number of specialties including infectious diseases, paediatrics and public health. The committee's recommendations are informed by public health advice and international best practice.

Immunisation is regarded as one of the safest and most cost-effective of health care interventions. The importance of immunisation is acknowledged by all the major international health organisations, particularly the World Health Organization (WHO).

Gardasil vaccine has been authorised for use across the European Union since September 2006. It was first introduced into the national immunisation programme in Ireland in 2010.

International studies and scientific assessments suggest that the best way to prevent most disease due to human papillomavirus (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 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 vaccine is a medicinal product authorised by the European Commission on 20 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.

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.

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.

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