Dáil Éireann Debate, Wednesday - 23 September 2015
110. Deputy Tom Fleming asked the Minister for Health if he will review the use of the anti-cervical cancer vaccine, Gardasil; if he will investigate the cases of the several school-going children experiencing health problems after receiving the vaccine; and if he will make a statement on the matter. [32474/15]
View answerImmunisation 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 the National Immunisation Advisory Committee (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.
In Ireland, the Health Products Regulatory Authority (HPRA) is the regulatory authority for medicines in Ireland. Gardasil® is a medicinal product which has been authorised for use across the European Union since September 2006 following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA). With this authorisation, the vaccine can be marketed in all EU Member States. Since first authorisation the HPRA has continuously monitored the safety of Gardasil®. This monitoring includes a review of global safety data in addition to national experience with use of the vaccine. The EMA is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.
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 15 July 2015, the Health Products Regulatory Authority (HPRA) has received 901 reports of suspected adverse reactions/events notified in association with the use of HPV vaccines (Gardasil® 899 and Cervarix® 2). 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 European Medicines Agency (EMA) is to evaluate data from a new epidemiological study on the safety of human papilloma virus (HPV) vaccines, Gardasil® and Cervarix®. The study conducted jointly by the French medicines agency (ANSM) and the French national health insurance fund (CNAMTS) compared the incidence of autoimmune conditions in girls given HPV vaccines with the incidence in girls not given the vaccines. In the meantime, the EMA have advised healthcare professionals that available data does not warrant any change to the use of these vaccines. Healthcare professionals should therefore continue using Gardasil® and Cervarix® in accordance with the current product information.
