Michael Moynihan (Cork North West, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

21. To ask the Minister for Health his response to concerns regarding the Gardasil vaccine; and if he will make a statement on the matter. [36258/15]

Leo Varadkar (Dublin West, Fine Gael)
Link to this: Individually | In context | Oireachtas source

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 when they are adults. 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.

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.