Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

138. To ask the Minister for Health the reason cases of suspected adverse reactions to the HPV vaccine Gardasil previously listed as convulsions were recently amended on the HPRA line listing report to seizures; if these amendments were notified to the EMA EudraVigilance database; if the attention of the case ID patient holder is drawn to such changes to their records; and if he will make a statement on the matter. [23836/18]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

The information that the Deputy seeks is not readily available.  Therefore, I have asked the Health Products Regulatory Authority (HPRA) to investigate the matter and reply directly to the Deputy.

It is important to reiterate that the HPRA and the European Medicines Agency continually monitor adverse events to vaccination.  HPV 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.  Mild and temporary reactions to any kind of vaccination are not unusual. 

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

139. To ask the Minister for Health his views on the long-term protection provided by the HPV vaccine Gardasil in view of information (details supplied); if a booster dose will be required; and if he will make a statement on the matter. [23837/18]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

The information that the Deputy seeks is not readily available. Therefore, I have asked the Health Products Regulatory Authority (HPRA) to investigate the matter and reply directly to the Deputy.

Clare Daly (Dublin Fingal, Independent)
Link to this: Individually | In context | Oireachtas source

140. To ask the Minister for Health the reason the HSE failed to provide parents with the HPV vaccine Gardasil manufacturer's package leaflet in the HSE parent information packs which promote the vaccine, particularly in view of the disclaimer contained on the HSE's website; and if he will make a statement on the matter. [23838/18]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

As this PQ relates to a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.