Tom Hayes (Tipperary South, Fine Gael)
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Question 118: To ask the Minister for Health and Children the information and studies taken into account in deciding to use Gardasil as a vaccine for the prevention of cervical cancer; and if she will make a statement on the matter. [47367/10]

Mary Harney (Dublin Mid West, Independent)
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The Irish Medicines Board (IMB), together with its EU counterparts is responsible for monitoring national and international emerging evidence about the safety of medicines, including vaccine safety.

The Health Information and Quality Authority (HIQA) was asked to establish the cost effectiveness of a combined national HPV vaccination and cervcial cancer screening programme. This assessment took account of the available evidence on the epidemiology of HPV and cervical cancer and included an assessment of the safety and efficacy of the HPV vaccines available. A copy of this report along with details of international evidence examined is available on the HIQA website at www.hiqa.ie.

The decision to proceed with a National HPV vaccination programme was also informed by the National Immunisation Advisory Committee (NIAC). This is represented in the NIAC Immunisation Guidance which can be found on the website at www.rcpi.ie. International evidence as to the safety profile and side-effects of vaccines is considered by NIAC in formulating its advice and is kept under constant review.

The public procurement process which was engaged by the HSE assessed the relative costs and benefits of the two HPV vaccines on the market and made recommendations on this basis in favour of the use of Gardasil.

Gardasil has been authorised by the European Commission for use across the European Union (EU) since 2006 and has been in widespread use in a number of Member States since then. In addition to the European approval, it is currently registered and authorised for use in 131 countries worldwide, including approvals by both the US Food and Drug Administration (FDA) and the Therapeutic Good Administration in Australia (TGA). More than 65 million doses of this vaccine have been distributed world-wide. The basis for the European Commission decision to authorise the product is contained in the European Public Assessment Report which is available on the website of the European Medicines Agency www.ema.europa.eu. Gardasil was licensed for use in Ireland in September 2007.

The highest priority is attached to ensuring the safety of all vaccines administered as part of the public immunisation programme in Ireland.