Thomas Pringle (Donegal South West, Independent)
Link to this: Individually | In context | Oireachtas source

643. To ask the Minister for Health his plans to address the concerns of parents over the Human Papilloma Virus (HPV) vaccine Gardasil; the level of his Department's engagement in an information campaign for parents, schools and children undergoing HPV vaccination; and if he will make a statement on the matter. [23781/15]

Leo Varadkar (Dublin West, 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). 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. 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.

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 and it is estimated that over 55 million girls and women have been vaccinated worldwide since it was first authorised.

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 31/05/2015, the Health Products Regulatory Authority (HPRA) has received 861 reports of suspected adverse drug reactions 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 published updates relating to national monitoring experience on its website during the first year of the HPV schools immunisation programme, with additional updates on national monitoring experience included in several editions of its Drug Safety Newsletter.