Dáil Éireann Debate, Tuesday - 21 April 2015
504. Deputy Regina Doherty asked the Minister for Health since the commencement of the human papilloma virus vaccine, the number of young persons who have had a reaction to it; the type of reaction, by category; the percentage of the young persons vaccinated who had a reaction; and if he will make a statement on the matter. [15573/15]
View answerGardasil® has been authorised 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 authorised for use in 133 countries worldwide, including approvals by both the US Food and Drug Administration (FDA) and the Therapeutic Good Administration in Australia. It is estimated that over 165 million doses of Gardasil® have been distributed worldwide since it was first authorised (figures to end of May 2014). Figures on national distribution and usage are available from the HSE.
Since first authorisation the Health Products Regulatory Authority (HPRA) has continuously monitored the safety of Gardasil®. This monitoring includes review of global safety data in addition to national experience with use of the vaccine.
Up to 20 April 2015, the HPRA has received 849 reports of adverse reactions associated with Gardasil®. The vast majority of these reports relate to adolescents, with a smaller number occurring in adults >18 years of age, which is reflective of Gardasil® usage as part of the national HPV immunisation programme. No new risks have been identified in association with national use of Gardasil®. The national monitoring experience has been consistent with the expected pattern of adverse effects for the vaccine, as outlined in the product information, including injection site reactions, malaise, headache, myalgia, fatigue, gastrointestinal symptoms and skin reactions (including urticaria). Vaccination related events such as dizziness and syncope were among the most commonly reported reactions. Hypersensitivity reactions have also been reported including a small number of anaphylactic-type reactions in patients, who have recovered following intervention and treatment. It is estimated that over 590,000 doses of Gardasil® have been distributed in Ireland to date since the commencement of the HPV schools immunisation programme.
