Michael Fitzmaurice (Roscommon-Galway, Independent)
Link to this: Individually | In context | Oireachtas source

370. To ask the Minister for Health his views on the use of the Gardasil HPV vaccine (details supplied) which some experts state contains genetically engineered subunit protein antigens that are capable of generating immune complexes; and if he will make a statement on the matter. [33618/16]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

The immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). The 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.

Each year in Ireland around 300 women are diagnosed with cervical cancer. The HPV vaccine protects against two high risk types of HPV (16 & 18) that cause 73% of all cervical cancers. Vaccinated women and girls will still be at risk from other high risk types of HPV that can cause cervical cancer and will therefore need to continue to have regular cervical smear tests. NIAC recommended that the human papillomavirus (HPV) vaccine be given to all girls aged 12-13 in 2009 and in September 2010 the HPV vaccination programme was introduced for all girls in first year of second level schools.

The European Commission granted a marketing authorisation valid throughout the European Union for Gardasil on 20 September 2006. By January 2016, over 200 million doses of Gardasil had been distributed worldwide. In Ireland over 580,000 doses of Gardasil have been administered and over 200,000 girls have been fully vaccinated against HPV since it was introduced in 2010. No medicine, including vaccines, is entirely without risk, there is therefore on-going pharmacovigilance and monitoring of medicinal products once they are authorised for use. The safety profile of Gardasil has been continuously monitored since it was first authorised.

It would be inappropriate for me to comment on the formulation of any pharmaceutical product authorised for use in the EU.