Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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196. To ask the Minister for Health whether he is aware that in July 2015 the European Medicines Agency started a review of human papilloma vaccines to further clarify aspects of their safety profile; his views on whether the administration of these vaccines should be deferred while this review is under way; if he is aware of the international concern that exists around this vaccine, for example, the health ministry in Japan has decided to withdraw its recommendation for this vaccine; and if he will make a statement on the matter. [38935/15]

Leo 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.

As of 9 October the HPRA 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.

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 Health Products Regulatory Authority is participating in the review which aims to clarify aspects of their safety profile and is specifically focusing on rare reports of two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndrome. Reports of these conditions in young women who have received a HPV vaccine have been previously considered during routine safety monitoring by the Pharmacovigilance and Risk Assessment Committee (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.

The HPRA is participating in the 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. Data from all Member States, including Ireland, is being comprehensively analysed, in line with usual ongoing referrals.

While the review is ongoing 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 them in accordance with the current product information. Any changes to this advice will be made following the outcome of the review, by the EMA.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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197. To ask the Minister for Health if he is aware that the information leaflet provided by the Health Service Executive to parents and guardians of girls due to receive the Gardasil vaccine does not fully outline the potential side effects of this medication; his views on whether this is acceptable; and if he will make a statement on the matter. [38936/15]

Leo 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.