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Vaccination Programme

Dáil Éireann Debate, Thursday - 22 October 2015

Thursday, 22 October 2015

Questions (13)

Michael Moynihan


13. Deputy Michael Moynihan asked the Minister for Health if he has received representations regarding the vaccination for Human Papilloma Virus; and if he will make a statement on the matter. [36259/15]

View answer

Written answers (Question to Health)

I am aware of and have been monitoring the situation in relation to the human papilloma virus (HPV) vaccine. The HPV vaccine protects women from developing cervical cancer. The vaccine 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.

In Ireland, the Health Products Regulatory Authority is the regulatory authority for medicines in Ireland. There are 2 licensed HPV vaccines available in Ireland (Gardasil® and Cervarix®). Gardasil® is the vaccine used by the HSE in the School Immunisation Programme.

While no medicine, including vaccines, is entirely without risk, the safety profile of Gardasil® has been continuously monitored since it was first authorised nationally and at EU level. This is done by monitoring both individual adverse reaction reports received by competent authorities across Europe and Periodic Safety Update Reports submitted by the Marketing Authorisation Holder for the vaccine on a regular basis. The introduction of new vaccines is based on the expert advice of the National Immunisation Advisory Committee. Decisions on the continued supply of vaccines into the market are undertaken by specific expert agencies rather than being the responsibility of the Minister of the day.

As of the 9 October, the Authority has received 921 reports of suspected adverse reactions or events notified in association with the use of HPV vaccines. The vast majority have been consistent with the expected pattern of adverse effects for the vaccines, as described in the product information, such as gastrointestinal symptoms, malaise, headache, dizziness and injection site reactions.

The European Medicines Agency has commenced a review of the HPV vaccine "to further clarify aspects of their safety profile," although the agency points out that this review "does not question that the benefits of HPV vaccines outweigh their risks." The review is specifically focusing on rare reports of two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndrome associated with heart rate increase.

The European Medicines Agency has advised healthcare professionals that available data does not warrant any change to the use of HPV vaccines. Healthcare professionals should therefore continue using Gardasil® and Cervarix® in accordance with the current product information.