Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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604. To ask the Minister for Health his views on the ongoing concerns regarding a matter (details supplied); the reassurance he can offer to the public; and if he will make a statement on the matter. [2894/20]

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 and vaccines that are licensed in Ireland. While no medicine (including vaccines) is entirely without risk, the safety profile of Gardasil, as with all medicines, is carefully monitored and any new evidence concerning side-effects is taken into account. HPV vaccine is one of the most closely studied and monitored medicinal products around. The HPRA and the European Medicines Agency (EMA) continually monitor adverse events to vaccination. 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 Patient Information Leaflet (PIL). These are usually mild and temporary reactions to any kind of vaccination. The Patient Information Leaflet provides information on the vaccine, its uses and on any precautions that require advice from a healthcare professional before it is administered.