Clare Daly (Dublin North, United Left)
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445. To ask the Minister for Health the steps he has taken to support the girls who have been diagnosed with Chronic Regional Pain Syndrome and Postural Orthostatic Tachycardia Syndrome (POTS) as a result of the Human Papilloma Virus vaccines; and if he has been in touch with the European Medicines Agency in relation to the Gardasil drug. [36167/15]

Billy Kelleher (Cork North Central, Fianna Fail)
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510. To ask the Minister for Health his views on concerns regarding the Gardasil vaccine; and if he will make a statement on the matter. [36520/15]

Leo Varadkar (Dublin West, Fine Gael)
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I propose to take Questions Nos. 445 and 510 together.

The immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). NIAC is a committee of the Royal College of Physicians of Ireland comprising of experts in a number of specialties including infectious diseases, paediatrics and public health. The committee's recommendations are informed by public health advice and international best practice.

Immunisation is regarded as one of the safest and most cost-effective of health care interventions. The HPV vaccine protects girls 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 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. The vaccine protects against two high risk types of HPV (16 & 18) that cause 73% of all cervical cancers. Vaccinated women and girls will still be at risk from other high risk types of HPV that can cause cervical cancer and will therefore need to continue to have regular cervical smear tests.

In Ireland, the Health Products Regulatory Authority (HPRA) 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. 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).

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.

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.

As of the 9 October 2015, the Health Products Regulatory Authority (HPRA) has received 921 reports of suspected adverse reactions/events notified in association with the use of HPV vaccines (Gardasil^®918 and Cervarix^®3). The vast majority of reports received by the HPRA regarding both Gardasil^®and Cervarix vaccines to date have been consistent with the expected pattern of adverse effects for the vaccines, as described in the product information.

The EMA has commenced a review of the human papilloma virus (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 HPRA is participating in the Pharmacovigilance and Risk Assessment Committee's (PRAC) review of HPV vaccines to clarify aspects of their safety profile. As for all licensed medicines, the safety of these vaccines is monitored by the PRAC (an EU level drug safety committee) where the HPRA is actively represented and contributes.

The current review will look at available data with a focus on rare reports of two conditions: complex regional pain syndrome (CRPS, a chronic pain condition affecting the limbs) and postural orthostatic tachycardia syndrome (POTS, a condition where the heart rate increases abnormally after sitting or standing up, causing symptoms such as dizziness and fainting, as well as headache, chest pain and weakness). Reports of these conditions in young women who have received a HPV vaccine have been previously considered during routine safety monitoring by the PRAC but a causal link between them and the vaccines was not established. Both conditions can occur in non-vaccinated individuals and it is considered important to further review if the number of cases reported with HPV vaccine is greater than would be expected. The outcome of the PRAC review is anticipated before the end of this year.

In addition the EMA is currently evaluating data from a 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.

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.