Written answers

Tuesday, 3 November 2015

Department of Health

Vaccination Programme

Photo of Anne FerrisAnne Ferris (Wicklow, Labour)
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853. To ask the Minister for Health the consent procedures afforded to parents of schoolgirls who are offered the human papilloma virus vaccine; the extent to which the consent procedures currently and previously included access to information on known side effects of the drugs in question; his views on the matter of consent procedures connected to the human papilloma virus vaccine; and the extent to which the Health Service Executive may be considered to be seeking fully informed parental and guardian consent. [38361/15]

Photo of Leo VaradkarLeo Varadkar (Dublin West, Fine Gael)
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As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy. If you have not received a reply from the HSE within 15 working days please contact my Private Office and they will follow up the matter with them.

Photo of Anne FerrisAnne Ferris (Wicklow, Labour)
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854. To ask the Minister for Health the extent and content of any interaction between his Department and the European Medicines Agency, regarding the review of human papilloma virus vaccines announced in July 2015; the interaction between the agency and any other State body on this review; the likely duration and scope of the review; his plans to publicise the review by the agency more widely, in order to invite comments from parents and vaccinated girls and women; and if he will make a statement on the matter. [38362/15]

Photo of Leo VaradkarLeo Varadkar (Dublin West, Fine Gael)
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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. 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.

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 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.

The European Medicines Agency (EMA) 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 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.

While the review is ongoing the EMA 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.

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