James Browne (Wexford, Fianna Fail)
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527. To ask the Minister for Health if a treatment protocol for children who suffer consequences that may be connected to a health procedure (details supplied) will be established; and if he will make a statement on the matter. [2656/20]

Simon Harris (Wicklow, Fine Gael)
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The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland. The HPRA operates a national adverse reaction reporting system, which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions to. All Reports received by the HPRA are routinely transmitted to the European Medicines Agency's adverse reaction database for inclusion in global signal detection and monitoring activities.

The HPRA and the European Medicines Agency (EMA) continually monitor adverse events relating to vaccination. Gardasil is one of the most closely studied and monitored medicinal products. The vast majority of reports received by the HPRA have been consistent with the expected pattern of short term adverse side effects for the vaccine, as described in the product information. The most frequently reported side effects are local redness and/or swelling at the point of injection and fever. Fainting has occurred after vaccination with Gardasil, especially in adolescents. Mild and temporary reactions to any kind of vaccination are not unusual.

It is important to reiterate that all medicines, including vaccines are subject to on-going review and evaluation of all available data from a range of sources, including systematic scientific literature review, to consider any impact that their data may have on the overall assessment of the benefits and risks of a medicinal product. Taking into account the totality of the available information, the benefits of the HPV vaccines continue to outweigh their risks. The safety of these vaccines continues to be monitored at EU level through the EMA and its expert committees, which includes representatives from member state competent authorities such as the HPRA.

I would also like to reassure any persons who are suffering ill health that they are eligible to seek medical attention, and to access appropriate health and social care services, irrespective of the cause of their symptoms. As there is no scientific evidence that the vaccine causes long term illnesses, the HPV vaccine cannot be held responsible for these illnesses.

I would urge any parent who has doubts or questions about vaccination to engage with their family doctor, or alternatively to visit the HPV website: hpv.ie.