Vaccination Programme

Dáil Éireann Debate, Tuesday - 26 February 2019

Tuesday, 26 February 2019

Ceisteanna (401)

Clare Daly

Ceist:

401. Deputy Clare Daly asked the Minister for Health his views on the HIQA health technology assessment report on extending the HPV vaccine to boys (details supplied); if HIQA included studies in its review that did not conform with the EU, European Medicines Agency, EMA, Health Products Regulatory Authority, HPRA, Food and Drug Administration, FDA, and World Health Organization, WHO, definition of a serious adverse event; and if so, the definition of such an event HIQA used to select relevant international literature for the purpose of its assessment. [9584/19]

Freagraí scríofa

Minister for Health

The Health Information and Quality Authority (HIQA) has advised that, in relation to their comprehensive safety assessment, included studies that reported serious and or minor adverse events associated with HPV vaccination. HIQA did not exclude studies based upon their definition of ‘serious adverse event’. Comparisons between studies were difficult as differing definitions were used. However, the within study comparisons of adverse event rates between HPV-vaccinated and non HPV-vaccinated individuals remain valid. Studies consistently show no increase in adverse event rates associated with the HPV vaccine.