Billy Kelleher (Cork North Central, Fianna Fail)
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556. To ask the Minister for Health his views on the concerns raised by Irish Vaccination Awareness in respect of the human papilloma virus vaccine (details supplied). [11123/15]

Leo 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. 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.

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.

The HPRA continues to ensure that the quality, safety & efficacy of all vaccinations licensed in Ireland including HPV meet the required standards. Internationally, the WHO monitors and reviews the safety of HPV vaccines.