Dáil Éireann Debate, Tuesday - 11 October 2016
477. Deputy Michael Fitzmaurice asked the Minister for Health the number of complaints that have been received each year from 2011 to 2016 by the national immunisation advisory committee, NIAC; the number of complaints received regarding the symptoms as described by the girls who made the complaints, in tabular form; and if he will make a statement on the matter. [29797/16]
View answer478. Deputy Michael Fitzmaurice asked the Minister for Health the principal role of the national immunisation advisory committee, NIAC, and the cost of this body in each of the years 2011 to 2015. [29798/16]
View answerI propose to take Questions Nos. 477 and 478 together.
In Ireland, the Health Products Regulatory Authority (HPRA) is the statutory regulatory authority for medicines in Ireland. This is achieved by both monitoring of individual adverse reaction reports received by competent authorities across Europe (including the HPRA) and Periodic Safety Update Reports submitted by the Marketing Authorisation Holder (i.e. license holder) for the vaccine on a regular basis. As part of its monitoring of the safety of medicines, the HPRA operates an adverse reaction reporting system, where healthcare professionals and patients are encouraged to report adverse reactions they consider may be associated with their treatment, through the range of options in place for reporting. All reports received are evaluated and considered in the context of the safety profile of the product concerned, with reports followed up as necessary for further information, that may assist in the assessment of the case. From the time of authorisation and up to 30th September 2016, the HPRA had received 1063 reports of adverse reactions and events associated with use of Gardasil. This level of reporting for Gardasil reflects the very positive response to calls from the HPRA for reporting of national experience associated with use of the vaccine, following its introduction into the national immunisation programme which commenced in May 2010.
The majority of reports received by the HPRA have been consistent with the expected pattern of adverse effects for the vaccines, as described in the product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)). Vaccination related events, occurring at the time of vaccine administration, such as syncope (faints) has been among the most commonly reported effects. Other commonly reported symptoms include gastrointestinal symptoms, malaise, headache, dizziness and injection site reactions. Reports of allergic-type reactions including skin rashes, urticaria and flushing have also been received, including isolated reports of more severe hypersensitivity-type reactions. There have also been some reports describing persisting/chronic fatigue, generally with multiple other symptoms (e.g. headache, malaise, drowsiness, nausea, gastrointestinal upset, joint swelling, flu like illness, menstrual disorders) following vaccination. The HPRA has informed me that a tabulated listing of case reports will be provided separately to the Deputy.
The National Immunisation Advisory Committee (NIAC) has no statutory role in the monitoring of adverse reaction to licensed medicinal products. NIAC was established within the Royal College of Physicians of Ireland in 1998. It comprises representatives from a broad range of medical and healthcare organisations. The role of NIAC is to provide expert, evidence-based, impartial guidance to the Chief Medical Officer in the Department of Health in the area of immunisation procedures and related matters. NIAC also prepares, and regularly updates, the Immunisation Guidelines for Ireland with the assistance of an active committee from associated disciplines in Paediatrics, Infectious Diseases, General Practice and Public Health. My Department does not provide any direct funding for the Committee.
