Dáil Éireann Debate, Thursday - 6 February 2014
185. Deputy Michael Healy-Rae asked the Minister for Health his views on whether the Gardasil HPV vaccination is safe (details supplied); if there is a possibility of side effects; and if he will make a statement on the matter. [5923/14]
Amharc ar fhreagraGardasil 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 42 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 and the balance of benefits and risks of the vaccine remain positive.
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 for Gardasil, including injection site reactions, malaise, headache, myalgia, fatigue, gastrointestinal symptoms and skin reactions. Vaccination related events such as dizziness and syncope (fainting) were among the most commonly reported effects. The Irish Medicines Board 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.
